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

Model Number FHC-A202-OBC511

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

Customer reported a false negative urine hcg test result with alere hcg cassette vs.Ultrasound.Information was received by telephone from distributor that a customer had an alere pregnancy test that gave a false negative result.The distributor stated that a urine hcg test was performed on a woman of child bearing age suspected of being pregnant.The urine test was performed at the 3 minute read time.The testing was performed a second time with the same result.On the same day, the pt had an ultrasound confirming she was pregnant (approximately 15/40 gestation).

Manufacturer Narrative

Customer's observation was not replicate din-house with retention product.Retention product were tested with hcg 20 miu/ml cutoff urine control and high level hcg positive urine controls; all results were positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without pt specimen in-house analysis.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subject to tracking and trending.

• Brand Name: ALERE HCG COMBO CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4114308
• MDR Text Key: 4943104
• Report Number: 2027969-2014-00851
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/19/2014

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: 01/31/2016
• Device Model Number: FHC-A202-OBC511
• Device Lot Number: HCG4040179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1