MAUDE Adverse Event Report: ALERE SAN DIEGO INC SURE-VUE SERUM/URINE HCG

Model Number FHC-202-OBC513

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

Customer reported a false negative urine hcg test with sure-vue serum/urine hcg vs.Positive results with serum.Customer was calling to ask about the cut-off for the test.They were trying to determine whether it was 25 m iu/ml urine or serum.They had no further patient information.The serum quant was unk; report says serum test was 'positive.' no adverse event reported.

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: SURE-VUE SERUM/URINE HCG
• 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: 3962581
• MDR Text Key: 4611599
• Report Number: 2027969-2014-00608
• 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: Not Applicable
• 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: 06/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: FHC-202-OBC513
• Device Lot Number: HCG3030193
• 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