MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG URINE CASSETTE 100T; HCG PREGNANCY TEST

Model Number	FHC-102
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 return products for the reported lot number were tested with quality control cut-off standard (25 miu/ml hcg urine) and high level hcg clinical urine (212.6, 215.2, and 221.9 iu/ml).All devices produced expected positive results at read time and met specifications.No false negative results were observed during testing.Review of manufacturing batch records did not uncover any abnormalities.The reported complaint for false negative results was not replicated during in-house testing as retention and return product performed as expected.Per the package insert, a very dilute urine specimen, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first-morning urine specimen should be collected 48 hours later and tested.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 alleged receiving false negative hcg results on six patients using the henry schein hcg urine cassette between 09/27/2018 and 10/03/2018.Per the customer, four of the six patients reported receiving a positive result on a home pregnancy test and one patient had proof of pregnancy.The customer was unable to identify which of the patients received a positive home pregnancy test result and which had proof of pregnancy.All patients were referred to their physicians as the facility provides a free screening service but does not treat patients.Although attempted, the customer declined troubleshooting but was sent a product information notice reaffirming current labeling.A separate mdr will be filed for each reported patient.Please refer to mdr#s 2027969-2018-00144, 2027969-2018-00145, and 2027969-2018-00147 to 2027969-2018-00149 for alternate five patients.

• Brand Name: HENRY SCHEIN HCG URINE CASSETTE 100T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8025564
• Report Number: 2027969-2018-00146
• Device Sequence Number: 11108189
• Product Code: JHI
• UDI-Device Identifier: 10304040024116
• UDI-Public: (01)10304040024116(17)200430(10)HCG8050023
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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-102
• Device Catalogue Number: 9004074
• Device Lot Number: HCG8050023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16.9 YR