MAUDE Adverse Event Report: ALERE MCKESSON HCG COMBO (25T) 32-202

Model Number FHC-202-0BW12

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

Customer reported a potential false negative mckesson hcg urine combo test result.Patient is a (b)(6) female, with unknown last menstrual period (lmp).Hcg urine tested on (b)(6) 2014 in the afternoon the mckesson hcg urine combo was negative, urine was clean, clear.Four (4) drops of urine onto the cassette and result was read at 3 minutes.Control line presented.Test line was missing.Background was clean.No serum was tested on his product or by other means.External quality control (qc) on the day was normal.No procedure was done to patient due to negative hcg result.The patient was expecting, therefore she came to office again on (b)(6) 2014 and serum was sent for quantification.The quantification serum test was positive at 303 miu.No additional information was provided.

Manufacturer Narrative

Investigation/conclusion: customer's observation was not replicated in-house with retention product.Retention product were tested with hcg 25 miu/ml cutoff urine control and 100 miu/ml hcg positive urine control, all results were positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover an 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 (25T) 32-202
• Manufacturer (Section D): ALERE; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4261989
• MDR Text Key: 18871025
• Report Number: 2027969-2014-00990
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-202-0BW12
• Device Lot Number: HCG4010152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/04/2014
• 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
• Patient Age: 27 YR