MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HCG HOME PREGNANCY TEST DEVICE

Model Number FHC-102HB-ONW01

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

Caller alleging receiving false negative hcg pregnancy results for multiple patients.Results received during the course of (b)(6).Patients' ages ranged from 20's and 30's.No patient medical and medication history was provided.Called reported quantitative tests were performed and the results were positive.Although attempts were made to obtain confirmation information, no verification was received from customer.False negative hcg results are non-confirmed.No other information is available.

Manufacturer Narrative

Customer's observation was not replicated in-house with retention devices.Retention devices were tested with hcg 25 miu/ml cutoff urine control and 3 high level hcg positive urine 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: HCG HOME PREGNANCY TEST DEVICE
• Type of Device: HCG HOME PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3983346
• MDR Text Key: 4890071
• Report Number: 2027969-2014-00632
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-102HB-ONW01
• Device Lot Number: HCG3100564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• 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