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

Model Number FHC-A102

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation conclusion.

Event Description

(b)(6) 2019: confirmed false positive result 4x on the consult diagnostics hcg cassette.Confirmatory testing provided a negative result (confirmatory test method and exact result unable to be provided).No treatment was provided or delayed based on the false positive results.No adverse patient outcomes reported.Although the specialist attempted to perform troubleshooting, the customer was unwilling to troubleshoot.

Manufacturer Narrative

(b)(6).Investigation conclusion: an investigation was performed on retention and returned devices from the reported lot number.Retention and returned devices were tested with clinical hcg-negative urine and results were read at 3 minutes.All devices produced expected negative results.No false positives were observed.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.The reported complaint was not replicated.A probable cause could not be determined based on the information available.Per the product insert: as with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse (hama) in the specimen.Specimens from patients who have received preparations of onoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: CONSULT HCG URINE CASSETTE
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 9148292
• MDR Text Key: 189234888
• Report Number: 2027969-2019-00566
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)201231(10)HCG9010049
• 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: 12/09/2019

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: 12/31/2020
• Device Model Number: FHC-A102
• Device Lot Number: HCG9010049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1