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

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation.

Event Description

Unspecified date: false positive result 3x on the consult hcg urine cassette when testing one patient.Although further information was requested, no further information was provided by the customer.

Manufacturer Narrative

Additional information: update to d10: device available for evaluation changed to no.Update to h3: although returned devices were requested, customer did not return devices for investigation.Update to h6: method code 11 added.Result code 213 added.Conclusion code 67 added.Investigation conclusion: retained product from the reported lot number was tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded the expected negative result.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.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.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.A root cause could not be determined from the available information, as the reported issue was not replicated during testing of retention 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: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 9495365
• MDR Text Key: 188856749
• Report Number: 2027969-2019-00613
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)210630(10)HCG9072026
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: FHC-A102
• Device Lot Number: HCG9072026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1