MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (25MIU/ML) 40T; HCG PREGNANCY TEST

Model Number	92217
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: retention product for the reported lot was tested with quality control cut-off standard (25miu/ml hcg urine).All devices were read at 3 minutes and yielded expected positive results.Manufacturing batch record review did not uncover any abnormalities.The reported complaint could not be replicated with retention product.Product performed as expected.This issue will continue to be monitored through incoming complaints.Case details indicate if the urine sample was not 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 patient's last menstrual period was (b)(6) 2018.On (b)(6) 2018, blood work was performed on the patient and a beta hcg quantitative result of 28 miu/ml was received.On (b)(6) 2018, the patient arrived at the facility for a scheduled dilation and curettage (d&c) procedure.A non-first morning urine sample was collected and an alere hcg cassette produced a negative hcg result.Per the customer, the physician suspects there was a possible miscarriage a few months ago.The patient has a history of persistent low hcg levels and gestational trophoblastic disease with heterophilic antibodies that do not cross over unto the urine.Based on the negative alere hcg cassette result, the physician elected to postpone the d&c procedure for one week.Although requested no additional information was provided by the customer.Troubleshooting was performed with the customer.Per the corresponding package insert, a number of conditions other than pregnancy, including trophoblastic disease can cause elevated levels of hcg.The 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.

• Brand Name: ALERE HCG CASSETTE (25MIU/ML) 40T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7939689
• Report Number: 2027969-2018-00129
• Device Sequence Number: 2305067
• Product Code: JHI
• UDI-Device Identifier: 10815845020109
• UDI-Public: (01)10815845020109(17)200229(10)HCG8030053
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 92217
• Device Lot Number: HCG8030053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR