MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (25 MIU/ML); HCG PREGNANCY TEST, PRODUCT CODE: JHI

Model Number 92217

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

Further investigation to determine whether the product failed to meet specifications cannot be pursued because the customer did not provide a lot number.The root cause cannot be determined due to insufficient information.No corrective action is required.No device return; no lot number.

Event Description

A (b)(6) female who has "behavior issues/possible mental health issues" was tested on (b)(6) 2017 and obtained a negative hcg result on the alere hcg urine cassette (lot number unknown).The date of her last menstrual period is unknown.On (b)(6) 2017, the patient stated she "was (b)(6) pregnant and was due in (b)(6)".No laboratory confirmatory testing or sonogram were performed.In addition, per the customer, the patient has had no prenatal visits to his knowledge.Patient stated she has a "history of having negative pregnancy tests when pregnant".No further information was provided.No reported adverse patient sequela.

• Brand Name: ALERE HCG CASSETTE (25 MIU/ML)
• Type of Device: HCG PREGNANCY TEST, PRODUCT CODE: JHI
• Manufacturer (Section D): ALERE SAN DIEGO, INC.
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6629802
• MDR Text Key: 77650281
• Report Number: 2027969-2017-00096
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/02/2017

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: 92217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/09/2017
• 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: N
• Patient Sequence Number: 1
• Patient Age: 34 YR