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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: retention and returned products were tested with hcg quality control cut-off standard (25miu/ml) and high level hcg clinical urine (212.6iu/ml, 215.2iu/ml, 221.9iu/ml).The testing results indicated that all strips yielded correct positive results on qc cut-off standard and high hcg clinical urine sample.False negative results were not observed.Product met qc release specification.Manufacturing batch record review did not uncover any abnormalities.The reported complaint could not be replicated with either returned or retention product.Therefore, a root cause could not be determined based on the information provided.This issue will continue to be monitored through incoming complaints.Case details do not indicate if the urine sample was a first morning catch.Per the package insert, very dilute urine may not contain representative levels of hcg.This test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Event or Problem Description
The customer reported receiving one false negative hcg result using a fisher - sure-vue hcg serum/urine test.Serum hcg confirmatory testing indicated the patient was positive for pregnancy.Although requested, no additional information was provided.

• 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: 7886612
• Report Number: 2027969-2018-00122
• Device Sequence Number: 186157
• Product Code: JHI
• UDI-Device Identifier: 00613647000540
• UDI-Public: (01)00613647000540(17)200229(10)HCG8030108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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 Expiration Date: 02/29/2020
• Device Model Number: FHC-202
• Device Lot Number: HCG8030108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1