MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (25MIU/ML) 40T; HCG PREGNANCY TEST

Model Number 92217

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's results were not replicated in-house with retention products of the reported lot.Retention products were tested with hcg urine standards at the qc cutoff and with clinical urine samples at three high hcg levels.All devices produced positive results at the read time and the product met the qc specification.False negative results were not observed during the investigation.Manufacturing batch record review did not uncover any abnormalities.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer reported the following events occurring on one patient: date of last menstrual period unknown.On (b)(6) 2017, the patient stated she "was (b)(6) pregnant and was due in (b)(6)." the patient had been previously tested using different lot of alere hcg cassette devices and received negative results on (b)(6) 2017 (refer to mdr 2027969-2017-00096).No confirmatory testing or sonogram was performed and to the customer's knowledge, the patient had not had any prenatal visits.On (b)(6) 2017, a patient urine sample was collected and produced a negative result using the alere hcg cassette.Patient had stated she has a "history of having negative pregnancy tests when pregnant".No additional information was provided.

• Brand Name: ALERE HCG CASSETTE (25MIU/ML) 40T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6655809
• MDR Text Key: 78133174
• Report Number: 2027969-2017-00105
• 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: consumer,health professional
• 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
• Device Lot Number: HCG5120111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/20/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR