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).All devices showed positive results at read time and met quality control specifications.No false negative results were obtained during in-house testing.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 two false negative hcg results using a fisher - sure-vue hcg serum/urine test on two patients.Serum hcg confirmatory testing indicated both patients were 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: 7886447
• Report Number: 2027969-2018-00121
• Device Sequence Number: 10820078
• 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