MAUDE Adverse Event Report: ALERE SAN DIEGO CARDINAL HEALTH RAPID TEST HCG CASS. 30T; HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation conclusion.

Event Description

It was reported that on (b)(6) 2019 at 1:08pm, a patient with symptoms of amenorrhea and a positive home pregnancy test with an unknown brand of test device, had a confirmed false negative result x1 on the hcg cassette test.The serum quant result was 149miu/ml.The staff repeated the test using the same sample and saw a faint line on the test region.Serum quant follow-ups were (b)(6) 2019 = 208 iu/l and (b)(6) 2019 = 304 iu/l.The customer did not have further information about the patient nor the effects of the false negative result.Although requested, there was no other information obtained.This file represents patient #3 2027969-2019-00377, patient #1 is represented in file 2027969-2019-0379, patient #2 is represented in file 2027969-2019-0378.Troubleshooting occurred with a discussion about the event and possible causes such as technique, storage, handling and patient sample.Possible causes reviewed with emphasis on limitations listed in the package insert.

Manufacturer Narrative

Investigation conclusion: an investigation was performed on retention and returned devices from the reported lot number.Retention and returned devices were tested with qc cut-off standard (25miu/ml hcg urine).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 on this lot for the reported issue and no systemic issue was 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 the patient's quantitative hcg result was 12 miu/ml.This is consistent with the negative result obtained on the cardinal health hcg cassette rapid test as the sensitivity level of the test is 25 miu/ml.The product is performing to specifications.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG CASS. 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9056933
• MDR Text Key: 192735845
• Report Number: 2027969-2019-00377
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: FHC-102
• Device Lot Number: HCG8110009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR