MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG URIN/SRM COMBO 5002 25; PREGNANCY TEST

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Customer / distributor unwilling to return / unresponsive.Investigation conclusion: an investigation was performed on retention devices from the reported lot number.Retention devices were tested with qc cut-off urine standard (20 miu/ml), qc cut-off serum standard (10 miu/ml), and high hcg (215.2 - 232.6 iu/ml) clinical urine.Results were read at 3 minutes for urine samples and at 5 minutes for serum samples.All devices produced expected positive results.No false negative results were observed.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Batch record review found no relevant non-conformances; the lot met all final release specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.The reported complaint was not replicated.Limited details regarding patient, product, and testing information could be obtained.A probable cause could not be identified based on the information available.Per the package insert: very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

Event Description

Unspecified date: false negative result on the consult diagnostics hcg urine/serum combo cassette kit.No adverse patient outcomes reported.Although requested, no further information was able to be provided.

• Brand Name: CONSULT HCG URIN/SRM COMBO 5002 25
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca
• Manufacturer Contact: monika burrell ; 9975 summers ridge road; san diego, ca ; 8052506
• MDR Report Key: 10370899
• MDR Text Key: 201871525
• Report Number: 2027969-2020-00041
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202768
• UDI-Public: (01)20612479202768(17)20430(10)HCG9050005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: FHC-A202
• Device Lot Number: HCG9050005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2020
• 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: Initial
• Patient Sequence Number: 1