MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER - SURE-VUE HCG SERUM/URINE (30T); HCG PREGNANCY TEST

Model Number FHC-202

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Code Available (3191)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: further investigation could not be pursued because lot hcg5100022 expired on (b)(6) 2017 prior to complaint intake.Customers should not use product past the expiration date.Manufacturing batch record review did not uncover any abnormalities.The lot met qc specification.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

On (b)(6) 2017, the patient was tested for pregnancy prior to performance of an x-ray.A urine sample was collected and a fisher - sure-vue hcg serum/urine test produced a negative hcg result.The x-ray was subsequently performed.The customer later discovered that product from this expired lot was mixed with the current lot in use by the facility and is unsure of the lot number of the fisher - sure-vue hcg serum/urine test used for this patient.Although no confirmatory testing was conducted, the customer believes the result may be false due to the possibility that the test used may have been expired.Although requested, no additional information including the patient outcome was provided.This event is being conservatively reported as the customer believes the use of expired product may have produced a false hcg result.

Manufacturer Narrative

(date of this report) corrected to date initial report was submitted to the fda: 01/09/2018.

• Brand Name: FISHER - SURE-VUE HCG SERUM/URINE (30T)
• 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: 7176919
• MDR Text Key: 96813236
• Report Number: 2027969-2018-00001
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993065
• 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,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: FHC-202
• Device Lot Number: HCG5100022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• 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 Outcome(s): Other
• Patient Age: 33 YR