MAUDE Adverse Event Report: ALERE SAN DIEGO ALERE HCG CASSETTE (25MIU/ML) 40T; HCG PREGNANCY TEST

Model Number 92217

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 10/29/2019

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 conclusion: customer's observation was not replicated in-house with retention and return products.Retention and return 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 insufficient information provided and without patient specimen in-house analysis.

Event Description

It was reported that there were 3 patients that had false positive results on the hcg cassette test.There was no confirmatory testing.This file, 2027969-2019-00554 is one of two files.This file represents two patients.File 2027969-2019-00272 represents the third patient.Troubleshooting included a discussion about potential sources of error including opening the foil pouch prematurely, flooding the device (dispensing more than 3 drops), interpreting past the designated read time (a sub-lod given enough time, nsb past 10-minutes mark), visible precipitate no allowed to settle/spin.

• Brand Name: ALERE HCG CASSETTE (25MIU/ML) 40T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9132150
• MDR Text Key: 190009784
• Report Number: 2027969-2019-00554
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 92217
• Device Lot Number: HCG5010091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1