MAUDE Adverse Event Report: ALERE SAN DIEGO MEDLINE HCG URINE CASSETTE; HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

Between the dates of 08/03/2020-11/23/2020, the medline hcg urine cassette was administered to 4 patients that were having symptoms of pregnancy, alleging 4 false negative results.Pregnancy was confirmed with positive testing results from area clinics.Although requested, no other information was provided.

Manufacturer Narrative

D9: yes; (b)(6) 2021.H3: yes.Investigation conclusion: retained and returned devices from the reported lot number were tested with qc cut-off standards (25 miu/ml) and high-hcg clinical urine samples (208.5-222.1 iu/ml).The results were read at 3 minutes and all devices yielded the 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.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control 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.A root cause could not be determined from the available information as the reported issue was not replicated during testing of either retention or returned product.However, case details indicate that the results were read no longer than 3 minutes after the sample was added to the device.Per the package insert, "hold the dropper vertically and transfer 3 full drops of urine (approx.100 microliters) to the specimen well (s) of the test device, and then start the timer; read the result at 3-4 minutes." the result should not be read before or after the appropriate read time.

• Brand Name: MEDLINE HCG URINE CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 11098602
• MDR Text Key: 240710937
• Report Number: 2027969-2020-00091
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30888277191871
• UDI-Public: (01)30888277191871(17)210731(10)HCG9082056
• 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
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: FHC-102
• Device Lot Number: HCG9082056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1