MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG ONE STEP PREGNANCY TEST (URINE/SERUM); HCG PREGNANCY TEST

Model Number FHC-202

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2014

Event Type  Injury  

Event Description

Caller alleged false negative hcg results for one patient.Results as follows: patient was tested for pregnancy before taking an x-ray picture with negative results.Afterwards it was determined that the patient was 5 weeks pregnant when the x-ray picture was taken.No other patient information was provided.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention and returned devices.Returned and retention devices were tested with cutoff urine and serum controls.All results were positive at read time.No false negative 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 ONE STEP PREGNANCY TEST (URINE/SERUM)
• 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: 3935462
• MDR Text Key: 4579591
• Report Number: 2027969-2014-00602
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-202
• Device Lot Number: HCG2100077
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/23/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other