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	10/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
On (b)(6) 2017, the patient arrived in the emergency department and a urine sample was collected.The alere hcg cassette produced a negative hcg result.The patient insisted she was pregnant and 10 minutes later a second alere hcg cassette produced a positive hcg result.The patient was determined to be (b)(6) pregnant.
Additional Manufacturer Narrative
The customer's observation was not replicated in-house with retention and return products.Retention and returned products were tested with qc cut-off hcg standards.All devices tested with qc cut-off standards showed positive results at read time and met qc specifications.Additionally, retain devices were tested with clinically negative urine samples all devices showed expected negative results at read time.No conflicting results were obtained 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.

• 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: 7109647
• Report Number: 2027969-2017-00184
• Device Sequence Number: 912686
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)190331(10)HCG7040129
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/14/2017

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: 03/31/2019
• Device Model Number: 92210
• Device Lot Number: HCG7040129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1