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	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
It was reported that on an unknown date, the patient tested herself on five at home urine pregnancy tests and obtained positive results x5.The test brand was unknown.Then on (b)(6) 2019, the patient presented to the facility to confirm the pregnancy.The patient's urine was tested on the henry schein hcg combo test and provided a negative result.Confirmatory bloodwork was then performed on the same day and provided a serum beta quant=212 miu/ml.There was no treatment provided or withheld based on the negative rapid result.No adverse patient event occurred.Troubleshooting was conducted with the customer.The customer was advised on possible causes of false negative results, such as deviations in storage, technique, and handling.The customer was also advised per the pi that this test provides only 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.
Additional Manufacturer Narrative
An investigation was performed on retention products for the reported lot number.Retention products were tested with qc cut-off hcg standard (25 miu/ml) and middle positive hcg standard (100 miu/ml).All devices produced expected positive results at the 3-minute read time.No negative results were observed.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.The reported complaint for a false negative hcg result was not replicated as retention products performed as expected.A root cause could not be determined based on the information available.Per the package insert, very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine or serum specimen should be collected 48 hours later and tested.Additionally, per the interfering substances section of the package insert, ibuprofen at a concentration of 20 mg/dl in hcg specimens has no interference in the assay.

• 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: 8553352
• Report Number: 2027969-2019-00078
• Device Sequence Number: 16708467
• Product Code: JHI
• UDI-Device Identifier: 10304040024123
• UDI-Public: (01)10304040024123(17)200930(10)HCG8100083
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 09/30/2020
• Device Model Number: FHC-202
• Device Catalogue Number: 9004075
• Device Lot Number: HCG8100083
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR