MAUDE Adverse Event Report: ALERE SAN DIEGO CARDINAL HEALTH RAPID TEST HCG CASSETTE; HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of investigation.

Event Description

The customer reported that on (b)(6) 2019, an hcg rapid test was administered using a urine sample which produced a false negative result.The beta serum quant result was 143 miu/ml and an ultrasound confirmed pregnancy.The patient was not provided/withheld treatment nor were there changes in medication due to the hcg results.

Manufacturer Narrative

Update to d4: udi number corrected.Investigation conclusion: an investigation was performed on retained devices from the reported lot number.Retained devices were tested with qc cut-off standard (25 miu/ml) and middle positive standard (100 miu/ml).Results were read at 3 minutes and all devices produced expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.It was reported that 3-4 drops of the patient urine sample was transferred to the test.Per the package insert, transfer 3 full drops of urine (approx.100 ul) to the specimen well of the test cassette.No further deviations regarding product storage and testing technique were observed.The reported issue was not replicated as retention product performed as expected.A probable cause could not be determined based on the information available.As stated in the product insert, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

Manufacturer Narrative

Update to section d10: date return was received by investigator was 17 dec 2019.Investigation conclusion: an investigation was performed on retention and returned products from the reported lot number.Retention and returned devices were tested with qc cut-off standard (25 miu/ml) and middle positive standard (100 miu/ml).Results were read at 3 minutes and all devices produced expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.It was reported that 3-4 drops of the patient urine sample was transferred to the test.Per the package insert, transfer 3 full drops of urine (approx.100 ul) to the specimen well of the test cassette.No further deviations regarding product storage and testing technique were observed.The reported issue was not replicated as retention product performed as expected.A probable cause could not be determined based on the information available.Per the product insert, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9269317
• MDR Text Key: 189217424
• Report Number: 2027969-2019-00595
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: FHC-102
• Device Catalogue Number: B1077-22
• Device Lot Number: HCG9030033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR