MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (20MIU/ML) 30T; HCG PREGNANCY TEST

Model Number	92210
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's observation was not replicated in-house with retention products.Retention products were tested with qc cutoff hcg concentrations standards.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.The serum quant for the patient was reported as 94 miu/ml.A dilute urine sample may make the hcg quant level much less than the serum levels which may lead to false results.Some patients may test negative early in pregnancy if the urine hcg is below 20 miu/ml.It is recommended that if pregnancy is suspected, a first morning urine specimen should be collected 48 hours later and tested.Because the specimen associated with the complaint was not returned for investigation, a root cause could not be determined based on the information provided.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 reported to be (b)(6) 2017.The patient received two positive hcg results on home pregnancy tests on (b)(6) 2017.On (b)(6) 2017, the patient went to facility to confirm pregnancy.A non-first morning urine sample was collected and an alere hcg cassette produced a negative hcg result at the read time of 3 minutes.However, the customer reported that a positive result developed at 4 minutes.A serum sample was collected and produced a positive hcg quantitative result of 94 miu/ml.The patient's urine sample was then sent to a sister facility and tested using a different lot of alere hcg cassettes.This event is reported under mdr 2027969-2017-00164.On (b)(6) 2017, the urine sample was also tested with a siemens clinitest hcg test and produced a positive hcg result.Troubleshooting was provided to the customer.The customer was advised some patients may test negative early in the pregnancy if the urine hcg is below the 20 miu/ml cut-off, or very dilute urine specimens may not contain representative levels of hcg.Per the package insert, if pregnancy is suspected, first morning urine should be collected 48 hours later and tested or alternate confirmatory methods should be considered.

• Brand Name: ALERE HCG CASSETTE (20MIU/ML) 30T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 6998312
• Report Number: 2027969-2017-00165
• Device Sequence Number: 1181518
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)190531(10)HCG7050058
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• 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
• Report Date (Section B): 10/09/2017

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 Expiration Date: 05/31/2019
• Device Model Number: 92210
• Device Lot Number: HCG7050058
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR