MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN ONE STEP + HCG URINE STRIP TEST; HCG PREGNANCY TEST

Model Number FHC-101

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

Customer reported potential false negative urine hcg results from two pts with the henry schein one step + hcg urine strip test.No quantitative test was performed; qualitative test was performed which gave positive results (lod unk).The only info provided was last menstrual period on one patient was 3 months ago and on the second pt one month ago.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with hcg cutoff urine control and hcg high level urine control; 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 patient specimen in-house analysis.Based on the info available, there is no indication of a product deficiency.No corrective action is required at this time.This issue will be subjected to tracking and trending.

• Brand Name: HENRY SCHEIN ONE STEP + HCG URINE STRIP 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: 3851858
• MDR Text Key: 4656239
• Report Number: 2027969-2014-00329
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-101
• Device Lot Number: HCG2110298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2014
• 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