MAUDE Adverse Event Report: ALERE SAN DIEGO CONSULT HCG URINE CASSETTE 5001 25T; HCG PREGNANCY TEST

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

The distributer reported that a women's health facility had false positive results on the hcg urine cassette initially providing a lot number.For one patient, the result for four tests with one specimen was 2 false positive results and 2 negative results with a negative serum test result.Subsequent contact with the customer revealed that the customer could not actually identify which lot number was used when the inaccurate results were obtained.The customer was not willing to provide additional details but would send the product back.On 01/22/2020, lot numbers: hcg9072026, hcg9040123, hcg9040084 were received.It is still unknown which lot was used at the time of the events.For this reason, one mdr will report this event.This mdr is associated with 2027969-2020-00010.

Manufacturer Narrative

Additional information: d4: actual lots unknown with these potential udi numbers (b)(4).D10: device returned 03/23/2020.G4: 03/30/2020.H3: yes.H6: method 4101; results 213; conclusions 67.Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative urine samples.The results were read at 3 minutes and all devices yielded the expected negative results.No false positive 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 retention or returned product.Per the package insert, 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: CONSULT HCG URINE CASSETTE 5001 25T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 9684773
• MDR Text Key: 189217893
• Report Number: 2027969-2020-00009
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: FHC-A102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1