MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG COMBO CASSETTE (20/10MIU/ML); HCG PREGNANCY TEST

Model Number 92215

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.The customer had three lot numbers of alere hcg combo cassettes (hcg8020008, hcg8040078, and hcg8030052) in the facility's inventory at the time of the false result.The customer was unable to confirm which of the three lot numbers was used to perform the single test on (b)(6) 2018.All three lot numbers will be investigated by the manufacturer.However, only a single mdr will be filed as only a single event was reported.Please find the details of the three potential complaint lots below: hcg8020008: (b)(4), expiration date 01/31/2020 - return received from customer 08/17/2018.Hcg8040078: (b)(4), expiration date 03/31/2020.Hcg8030052: (b)(4), expiration date 02/29/2020.

Event Description

On (b)(6) 2018, the patient arrived at the emergency room for an unspecified reason.A urine sample was collected and an alere hcg combo cassette produced a negative hcg result.The sample was likely a non-first morning urine and had a specific gravity of 1.020.The customer was unable to confirm the read time of the test.Per the customer, the negative hcg result was questioned and a confirmatory test was ordered.However, the customer was unable to confirm why the result was questioned.A serum quantitative test using an in-house dxi analyzer produced an hcg result of 48,925 miu/ml.On (b)(6) 2018, the customer tested the original urine sample from (b)(6) 2018 using the three lot numbers of alere hcg combo cassettes available in the facility's inventory and obtained three positive hcg results at a read time of 3 minutes.The customer had three lot numbers of alere hcg combo cassettes (hcg8020008, hcg8040078, and hcg8030052) in the facility's inventory at the time of the false result.The customer was unable to confirm which of the three lot numbers was used to perform the single test on (b)(6) 2018.Troubleshooting was conducted with the customer.The customer was advised of the importance of interpreting the test at the designated read time and using a timer.

Manufacturer Narrative

Investigation conclusion: the customer had three lot numbers of alere hcg combo cassettes (hcg8020008, hcg8040078, and hcg8030052) in the facility's inventory at the time of the false result.The customer was unable to confirm which of the three lot numbers was used to perform the single test on 08/05/2018.All three lot numbers were investigated by the manufacturer.Please see below: hcg8020008: udi (b)(4) , expiration date 01/31/2020 an investigation was performed on retention product for the reported lot number.Retention product was tested with qc cut-off standard (20miu/ml), high positive standard (10iu/ml) and high hcg 215.2iu/ml clinical urine sample.All devices produced expected positive results at read time and met qc specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities and all quality control specifications were met.Return product was received from customer on 08/17/2018 and subsequently forwarded for testing.However, the returned product was unable to clear customs and therefore further investigation could not be conducted.Hcg8040078: udi (b)(4) expiration date 03/31/2020 an investigation was performed on retention products for the reported lot number.Retention devices were tested with qc cutoff standards (20 miu/ml), high-hcg positive standards (10 iu/ml), and high-hcg clinical urine samples (215.2 iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and the lot met quality control specifications.Retention devices were also tested with the returned urine sample from the patient.Results were read at 3 minutes and all devices produced positive results with strong control and test lines.No false negative results were observed during in-house testing.Hcg8030052: udi (b)(4) expiration date 02/29/2020 an investigation was performed on retention products for the reported lot number.Retention devices were tested with qc cutoff standards (20 miu/ml), high-hcg positive standards (10 iu/ml), and high-hcg clinical urine samples (215.2 iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and the lot met quality control specifications.Quantitative hcg analysis was performed on the returned urine sample.The mean of the results was 3,580 miu/ml; this is consistent with the positive results observed during testing on lot hcg8040078.A root cause could not be determined from the available information as retention devices performed as expected.Alere san diego will continue to monitor this issue through incoming complaints.Based on the information available, there is no indication of a product deficiency and no corrective action is required.(device evaluated by manufacturer?) selected as no: other.Return product from lot hcg8020008 was received from customer on 08/17/2018 and subsequently forwarded for testing.However, the returned product was unable to clear customs and therefore further investigation could not be conducted.

Manufacturer Narrative

Investigation conclusion: the customer had three lot numbers of alere hcg combo cassettes (hcg8020008, hcg8040078, and hcg8030052) in the facility's inventory at the time of the false result.The customer was unable to confirm which of the three lot numbers was used to perform the single test on (b)(6) 2018.All three lot numbers were investigated by the manufacturer.Please see below: hcg8020008: udi (b)(4), expiration date 01/31/2020.An investigation was performed on retention product for the reported lot number.Retention product was tested with qc cut-off standard (20miu/ml), high positive standard (10iu/ml) and high hcg 215.2iu/ml clinical urine sample.All devices produced expected positive results at read time and met qc specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities and all quality control specifications were met.Return product was received from customer on 08/17/2018 and subsequently forwarded for testing.However, the returned product was unable to clear customs and therefore further investigation could not be conducted.Hcg8040078: udi (b)(4), expiration date 03/31/2020.An investigation was performed on retention products for the reported lot number.Retention devices were tested with qc cutoff standards (20 miu/ml), high-hcg positive standards (10 iu/ml), and high-hcg clinical urine samples (215.2 iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and the lot met quality control specifications.Hcg8030052: udi (b)(4), expiration date 02/29/2020 an investigation was performed on retention products for the reported lot number.Retention devices were tested with qc cutoff standards (20 miu/ml), high-hcg positive standards (10 iu/ml), and high-hcg clinical urine samples (215.2 iu/ml).Results were read at 3 minutes and all devices yielded expected positive results.No false negative results were observed during in-house testing.Manufacturing batch record review did not uncover any abnormalities and the lot met quality control specifications.Quantitative hcg analysis was performed on the returned urine sample.The mean of the results was 28,660 miu/ml.A root cause could not be determined from the available information as retention devices performed as expected.Alere san diego will continue to monitor this issue through incoming complaints.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Section h3 (device evaluated by manufacturer?) selected as no: other.Return product from lot hcg8020008 was received from customer on 08/17/2018 and subsequently forwarded for testing.However, the returned product was unable to clear customs and therefore further investigation could not be conducted.

• Brand Name: ALERE HCG COMBO CASSETTE (20/10MIU/ML)
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7852374
• MDR Text Key: 119933103
• Report Number: 2027969-2018-00113
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 92215
• Device Lot Number: UNKNOWN - REFER TO H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1