MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG COMBO CASSETTE (25); HCG/PREGNANCY

Model Number FHC-202

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

Caller alleged false negative hcg results on two lots.Results as follows: one patient sample gave a false negative hcg result on two lots.The customer did not believe the test result, so they had a quantitative serum test done that came out to approx 35miu/ml.The same urine sample was ran on their chemistry analyzer and received 37miu/ml, though the customer states urine is not approved for use on their chemistry analyzer.They then tested a third lot of the same alere hcg test and it showed a positive result.The customer also prepared hcg dilutions for a sample approx 25miu and it showed negative on the initial two lots and positive on the most recent third lot of the alere hcg test.The customer suspects that the patient had an ectopic pregnancy or had miscarried, but could not provide any further details.No treatments or procedures were performed on the basis of the false negative results.The patient was treated according to the serum quantitative result.Additional information: external controls were previously done with alere brand controls and were ok; internal control was showing up; sample was fresh and at room temperature for initial testing; no urinalysis was performed but the urine appeared normal and clear; no sample remains to return; test was read at 3 minutes using a timer.Refer to mdr #2027969-201401060 for second lot number.

Manufacturer Narrative

Customer's complaint was not replicated in-house with retention devices.Retention devices were tested with cutoff hcg urine control and 3 high level hcg urine controls.All results were positive at read time.Manufacturing batch record review did not uncover any abnormalities.Patient's serum sample was quantified at approx 35 miu/ml.Hcg levels in serum are usually higher than in urine.Hcg levels in urine may have been determined without patient specimen in-house analysis.Product deficiency was not established.This issue will be tracked and trended.Corrective action is not required at this time.

• Brand Name: ALERE HCG COMBO CASSETTE (25)
• 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: 4322860
• MDR Text Key: 18545230
• Report Number: 2027969-2014-01059
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• 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: HCG3120156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• 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