MAUDE Adverse Event Report: ALERE SAN DIEGO HENRY SCHEIN HCG URINE CASSETTE 25T; HCG PREGNANCY TEST

Model Number FHC-102

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

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: the customer's results were not replicated in-house with returned or retention products of the reported lot.Retention and returned devices were tested with in-house clinical hcg negative urine samples.All hcg results with retained and returned devices were negative at read time.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined from the information provided.

Event Description

It was reported that a post menopausal woman who was scheduled for surgery was administered an hcg cassette test with a positive result.No confirmatory testing was performed.Unconfirmed false positive results on one step+ hcg urine cassette.Hcg screening was a part of the facilities protocol before surgery.Customer states no treatment was provided/withheld based on the false positive results.Customer tested patient samples on alternate lot and obtained a negative result (lot number not provided).Troubleshooting occurred with a discussion about possible causes for unexpected results focusing on proper sampling technique and storage conditions per pi-no deviations noted.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE 25T
• 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: 9114363
• MDR Text Key: 191852094
• Report Number: 2027969-2019-00412
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: FHC-102
• Device Lot Number: HCG6120095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• 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