MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG COMBO DEVICE SP BRAND RAPID TEST; HCG PREGNANCY TEST

Model Number FHC-A202-OBW515

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

Customer reported a false negative urine pregnancy result with hcg combo device sp brand rapid test vs.Quantitative test.A (b)(6) year old female patient came to the e.R.In the evening.A urine test was performed using hcg combo device sp brand rapid test with a clearly negative reading at 3 minutes.Patient said she had done a home pregnancy test and that test was positive.A quantitative test was done and the result was 30.85 miu/ml.No adverse event reported.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention product.Retention product were tested with hcg 20 miu/ml urine positive control (n=29), all hcg 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 patient 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: HCG COMBO DEVICE SP BRAND RAPID TEST
• 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: 4139724
• MDR Text Key: 4917993
• Report Number: 2027969-2014-00887
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202-OBW515
• Device Lot Number: HCG4020052
• Was Device Available for Evaluation?: No
• Date Manufacturer 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
• Patient Age: 36 YR