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

Model Number FHC-102-KHS25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

Caller alleged false negative hcg results using two different lot numbers.Results as follows: an office worker who is confirmed to be pregnant took hcg tests using two different boxes.Both tests came back negative after 5 minutes, but then showed positive after 10 minutes.Refer ro mdr #2027969-2014-01085 for second lot number.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention product.Retention product was tested with cutoff hcg urine controls and 3 high level hcg positive controls.All hcg results were positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Unable to determine root cause 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: HENRY SCHEIN ONE STEP + HCG URINE CASSETTE TEST
• Type of Device: HCG PREGNANCY
• 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: 4356082
• MDR Text Key: 18034840
• Report Number: 2027969-2014-01084
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102-KHS25
• Device Lot Number: HCG4020038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• 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