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

Model Number	92210
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
Results pending investigation.
Event or Problem Description
Unspecified date: patient presented to facility after obtaining a positive result on a home pregnancy test (brand/specificity unspecified).Urine specimen tested on the alere hcg cassette and a negative result was obtained.A confirmatory blood hcg was performed and the result was positive at >100 (units not able to be confirmed).No adverse patient outcomes reported.Although further information was requested, no further information was provided.
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with cut-off standards and middle positive standards.The results were read at 3 minutes and all devices yielded the expected positive results.No false negative results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product.Per the package insert, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg.False negative results may occur when the levels of hcg are below the sensitivity level of the test.Very dilute urine specimens, 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.Additionally, per the quality control section of the package insert, it is recommended that a positive hcg control (containing greater than or equal to 20 miu/ml hcg in urine) and a negative hcg control (containing "0" miu/ml hcg) be evaluated to verify proper test performance with each new lot, each new shipment, monthly as a check on storage, each new untrained operator and as otherwise required by your lab internal quality system procedures.

• Brand Name: ALERE HCG CASSETTE (20 MIU/ML)
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego, ca
• MDR Report Key: 9886803
• Report Number: 2027969-2020-00016
• Device Sequence Number: 2941588
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)210630(10)HCG9072132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993317
• 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): 05/13/2020

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: 06/30/2021
• Device Model Number: 92210
• Device Lot Number: HCG9072132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1