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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

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 an hcg urine standard at the qc cutoff as well as a middle positive hcg urine standard.All devices produced expected positive results at the read time.The product met the qc release 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: on (b)(6) 2017, a urine sample was collected from the patient and produced two negative hcg results using two innovacon hcg urine devices.A laboratory test was performed the same day and produced an hcg result of 236 iu/l.No treatment or intervention was provided or withheld based on the innovacon hcg urine results.The customer also provided information regarding two additional false negative results occurring on the same patient but a different lot number.These events are being reported under mdr# 2027969-2017-00122.

• Brand Name: INNOVACON HCG URINE
• 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: 6742537
• MDR Text Key: 81012726
• Report Number: 2027969-2017-00121
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K993317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/03/2017

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: FHC-102
• Device Lot Number: HCG5060130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/25/2017
• 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