MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG CASSETTE; HCG PREGNANCY TEST

Model Number FHC-A102-OBC554

Device Problem False Negative Result (1225)

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

Event Date 02/19/2014

Event Type  malfunction  

Event Description

Customer reported potential false negative urine hcg result for multiple patients that were confirmed pregnant.The customer stated it is their normal protocol to run a urine pregnancy test for all patients when they come in for their first visit even if they know the patient is pregnant based on home pregnancy tests or blood tests.Several known positive pts produced negative results on the pss urine cassette when they were first tested.When a negative result was received, the techs repeated the test using the same sample and a new test device.The repeat testing would often show clear positive results the 2nd or 3rd time the sample was tested.The techs are experienced users and they only observed the issue with the 2 boxes the customer just received from pss.The issue occurred for multiple pts that were all around 8-10 weeks pregnant.No harm came to any of the patients based on the initial negative result.No further info was provided.

Manufacturer Narrative

Customer did not provide a lot number.Unable to perform retain product testing.No further investigation is possible due to insufficient event details.Unable to determine root cause from the info provided.A review of complaints against this product and trend corrective action required at this time as no product deficiency was established.

• Brand Name: CONSULT DIAGNOSTICS HCG CASSETTE
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3770330
• MDR Text Key: 4444752
• Report Number: 2027969-2014-00201
• Device Sequence Number: 1
• Product Code: JHI
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2014

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-A102-OBC554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/07/2014
• 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