MAUDE Adverse Event Report: ALERE SAN DIEGO CARDINAL HEALTH RAPID TEST HCG COMBO 30T; HCG PREGNANCY TEST

Model Number FHC-A202

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Product not available for return.Results pending investigation.

Event Description

The customer alleges 4 questionable results with 4 patients using the cardinal health rapid hcg combo test.Although requested, the customer did not describe what made the results questionable.Confirmatory testing was performed for these 4 results, method and quantitative results were requested but not provided as well.There was no harm nor treatment given or not given due to the discrepant result since there was confirmatory labs performed.This mdr is being conservatively filed due to the questionable results potentially alleging false positive or false negative results.

Manufacturer Narrative

D4: added udi.H3: selected "not returned to manufacturer".Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine and serum samples.The results were read at 3-4 minutes and 5-6 minutes respectively, and all devices yielded the expected negative results.Retained devices were also tested with cut-off standards for urine and serum.The results were read at 3 minutes and 5 minutes respectively, all devices yielded the expected positive results.No false 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.No details regarding technique, storage, or handling could be obtained.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 packet insert: · 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.· 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 serum or urine specimen should be collected 48 hours later and tested.· very low levels of hcg (less than 50 miu/ml) are present in serum and urine specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning serum or urine specimen collected 48 hours later.· this test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.· a number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in a serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.· as with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.· 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.

• Brand Name: CARDINAL HEALTH RAPID TEST HCG COMBO 30T
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 12297471
• MDR Text Key: 265799470
• Report Number: 2027969-2021-00073
• Device Sequence Number: 1
• Product Code: JHI
• 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
• Report Date: 08/23/2021

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: 12/31/2022
• Device Model Number: FHC-A202
• Device Lot Number: HCG1012027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1