MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG COMBO 25T; 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)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
The distributor reported the event on behalf of the customer.On (b)(6) 2018, the patient presented at the facility to confirm a positive home pregnancy test.Per the customer, the home pregnancy test resulted in a "faint positive." a urine sample was collected and a henry schein hcg combo test produced a negative hcg result.The physician ordered blood work and a serum beta hcg quantitative test produced a result of 127,613 miu/ml.The patient was provided with prenatal care.Troubleshooting was conducted with the customer.The customer was determined to be using non-validated controls (quantimetrix).
Additional Manufacturer Narrative
Investigation conclusion: retention and return products for the reported lot number were tested with high hcg clinical urine samples (212.6, 215.7, 221.9 iu/ml).All devices produced expected positive results at the read time.No false negative results were observed.Review of manufacturing batch records did not uncover any abnormalities and quality control data met specifications.A root cause could not be determined as retention and return products performed as expected.Per the package insert, 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.

• Brand Name: HENRY SCHEIN HCG COMBO 25T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7915363
• Report Number: 2027969-2018-00123
• Device Sequence Number: 10998216
• Product Code: JHI
• UDI-Device Identifier: 10304040024123
• UDI-Public: (01)10304040024123(17)200430(10)HCG8050024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 04/30/2020
• Device Model Number: FHC-202
• Device Catalogue Number: 9004075
• Device Lot Number: HCG8050024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR