MAUDE Adverse Event Report: ALERE SAN DIEGO FISHER - SURE-VUE HCG URINE CASS. (30T); HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

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 an 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 (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 with in-house clinical hcg negative urine samples and all hcg results were negative at read time and met qc specification.No false positives were obtained.Mfg batch record review did not uncover any abnormalities.The root cause could not be determined based on the information provided and with out patient specimen in-house analysis.

Event Description

The customer reported false positive on the hcg test results with 2 patients using serum samples with no abnormalities noted.Unknown tests completed for confirmatory testing which had negative results.Although requested, no further information has been received.Troubleshooting occurred with a discussion of the possible causes for unexpected results focusing on proper technique, sample collection and potential interferences.

• Brand Name: FISHER - SURE-VUE HCG URINE CASS. (30T)
• 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: 9132135
• MDR Text Key: 160502870
• Report Number: 2027969-2019-00553
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• 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: 08/31/2017
• Device Model Number: FHC-102
• Device Lot Number: HCG5080086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: No
• 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