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

Model Number FHC-202

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

Caller alleges receiving one false negative urine hcg.Patient presented (b)(6) 2014, urine on mckesson hcg combo assay rang negative.Patient stated home pregnancy tests rang positive (no details).On (b)(6) 2014, bloodwork was performed and the serum quant was 307 miu/ml.It was explained to the customer that taking into consideration that hcg concentration doubles daily, and that urine levels are typically half that of the serum levels - the 307 on (b)(6) 2014 would have been approximately 153 on the day the urine was tested, and half of 153 would be approximately 72, now incorporate hydration status since not a first morning specimen.Customer receptive and feels the urine may have been a borderline concentration.Customer did not run the test, cannot verify that the result was interpreted at the 3 minute read time.Customer cannot rule out the possibility that the technician may have interpreted the result upon pc line being evident, prior to the designated read time.No reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention product.Retention product were tested with hcg 25 miu/ml cutoff urine/serum control and 100 miu/ml hcg positive urine/serum 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 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: MCKESSON HCG COMBO
• 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: 4139718
• MDR Text Key: 20455678
• Report Number: 2027969-2014-00888
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2014

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-202
• Device Lot Number: HCG4010152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2014
• 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