MAUDE Adverse Event Report: ALERE SAN DIEGO MEDLINE HCG COMBO CASSETTE; HCG PREGNANCY TEST.

Model Number FHC-A202

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

It was reported that false negatives were occurring with no confirmatory information.Although requested, no further information has been provided.There was no adverse event nor injuries reported.

Manufacturer Narrative

D9: no.H3: not returned to the manufacturer.Investigation conclusion: retained devices from the reported lot number were tested with qc cut-off urine standards 20 miu/ml) and high-hcg clinical urine samples (212.0-215.6 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.Retained devices were also tested with qc cut-off serum standards (10 miu/ml).The results were read at 5 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.Complaints are tracked and trended on a monthly basis.Per the package insert, 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.This test provides a presumptive diagnosis for pregnancy.A confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

Manufacturer Narrative

D9: device available for evaluation.Yes.(b)(6) 2021.H3: yes.Investigation conclusion: retained and returned devices from the reported lot number were tested with qc cut-off urine standards (20 miu/ml) and high-hcg clinical urine samples (205.7-222.1 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.Retained devices were also tested with qc cut-off serum standards (10 miu/ml).The results were read at 5 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 either retention or returned product.Complaints are tracked and trended on a monthly basis.Per the package insert, 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.This test provides a presumptive diagnosis for pregnancy.A confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: MEDLINE HCG COMBO CASSETTE
• Type of Device: HCG PREGNANCY TEST.
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 11013674
• MDR Text Key: 246835902
• Report Number: 2027969-2020-00090
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 30884389191884
• UDI-Public: (01)30884389191884(17)220331(10)HCG0032114
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: FHC-A202
• Device Lot Number: HCG0032114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/29/2020; 04/19/2021
• Supplement Dates FDA Received: 12/29/2020; 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1