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

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's results were not replicated in-house with retention devices of the reported lot.Retention devices were tested with hcg-positive urine at the qc cutoff and with an additional hcg-positive urine standard.All of the results were hcg-positive at read time and met the qc specification.No false negative results were observed 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.

Event Description

The point of care coordinator reported the following events occurring on one patient: on (b)(6) 2017, a urine sample was collected from the patient and produced a negative result using a fisher sure-vue hcg urine cassette.The urine sample was a yellow, hazy first-morning specimen.Specific gravity = 1.015.Blood in urine = 3+.Urine ph = 6.Urine rbc = 40-50.Urine epithelial cells = 1-2.The same day a hcg beta quant was performed and produced a result of 1000 miu/ml.The point of care coordinator stated that he believes the nurse performing the test may have misread the fisher sure-vue hcg urine cassette result.Although requested, no additional information was provided.

• Brand Name: FISHER - SURE-VUE HCG URINE CASS. (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: 6582128
• MDR Text Key: 75772687
• Report Number: 2027969-2017-00092
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00613647000526
• UDI-Public: (01)00613647000526(17)180831(10)HCG6090100
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• 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: HCG6090100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• 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: 32 YR