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 Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: customer's observation was not replicated in-house with retention products.Retention (n=29) devices were tested in-house clinical hcg negative urine samples, all results were negative at 3 minutes read time and met qc specification.No false positives were obtained.Mfg batch record review did not uncover any abnormalities.Root cause could not be determined from the information provided and without patient specimen in-house analysis.

Event Description

It was reported that on (b)(6) 2015, the patient was tested on the consult hcg urine cassette and received a false positive result.A confirmatory blood test was performed and verified the false positive result.Further information was not available.

Manufacturer Narrative

At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere san diego.Alere san diego updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere san diego (reference eir 1000125596).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results customer's observation was not replicated in-house with retention products.Retention (n=29) devices were tested in-house clinical hcg negative urine samples, all results were negative at 3 minutes read time and met qc specification.No false positives were obtained.Mfg batch record review did not uncover any abnormalities.Root cause could not be determined from the information provided and without patient specimen in-house analysis.

Event Description

It was reported that a false positive occurred with an hcg urine cassette test.The patient had a tubal ligation.The office protocol is to have a negative hcg test.No other information was received.This file, 2027969-2019-00142 is one of 2 files.The second file is 2027969-2019-00543.

• 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: 9130853
• MDR Text Key: 191247854
• Report Number: 2027969-2019-00142
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

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: 10/31/2015
• Device Model Number: FHC-A102
• Device Lot Number: HCG4010136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1