MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER - SURE-VUE HCG SERUM/URINE (50T); HCG PREGNANCY TEST

Model Number	FHC-202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
On (b)(6) 2017, a urine sample was collected from the patient at 10:00 pm and tested using a fisher - sure-vue hcg serum/urine cassette at 10:38 pm.The customer reported receiving a negative hcg result at the 3 minute read time but observed a faint line that developed at 4 minutes.The test was repeated using a second fisher - sure-vue hcg serum/urine cassette and another negative hcg result was received at the 3 minute read time.A serum sample was then obtained from the patient and produced a positive hcg result at the 5 minute read time using a third fisher - sure-vue hcg serum/urine cassette.A serum quantitative test was also performed on the same day and yielded an hcg result of 47 miu/ml.On (b)(6) 2017, a second serum quantitative test was performed for the patient and yielded an hcg result of 83 miu/ml.
Additional Manufacturer Narrative
Investigation conclusion: the customer's observation was not replicated in-house with retention and return products.Retention and return products were tested with qc cutoff standard hcg concentration.All devices showed positive results at read time and met qc specifications.No false negative results were obtained during in-house testing.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.

• Brand Name: FISHER - SURE-VUE HCG SERUM/URINE (50T)
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 6959724
• Report Number: 2027969-2017-00156
• Device Sequence Number: 16366645
• Product Code: JHI
• UDI-Device Identifier: 00613647000540
• UDI-Public: (01)00613647000540(17)190131(10)HCG7010129
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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
• Operator of Device: Health Professional
• Device Model Number: FHC-202
• Device Lot Number: HCG7010129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR