MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG DIPSTICK; PREGNANCY TEST

Model Number 92211

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation conclusion.

Event Description

Unspecified date: false negative result on the alere hcg dipstick kit when testing multiple patients.Alternate testing method provided a positive result (unable to specify whether the patients tested with an at-home pregnancy test or if patients were tested at a different facility).No treatment was provided or withheld based on the false negative results.No adverse patient outcomes reported.Although further information was requested, no further information was provided.

Manufacturer Narrative

Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.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.No lot number could be obtained, therefore retain testing and manufacturing record review could not be performed.A root cause could not be determined from the available information.Per the package insert, 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.

• Brand Name: ALERE HCG DIPSTICK
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 9148294
• MDR Text Key: 189232283
• Report Number: 2027969-2019-00567
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 92211
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1