MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CARDINAL RAPID TEST HCG COMBO; 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 04/14/2023

Event Type  malfunction  

Event Description

The customer reported the patient presented for hcg testing with the cardinal health hcg rapid test prior to having an unknown procedure requiring anesthesia.A fresh urine sample was provided by the customer on (b)(6) 2023 at 0930.The customer indicated the patient's urine was yellow, however no details were provided regarding the presence of visible contaminants or precipitates.The customer indicated the first test device appeared to be positive at the 4-minute read time.The customer then tested the patient again with an additional device from the same lot and a negative result was observed at the 4-minute read time.A third test was performed which appeared negative at 3-4 minutes and positive at 5 minutes.Due to the discrepant results, the procedure was cancelled, and the patient was sent for confirmatory testing.On (b)(6) 2023, it was reported that the result of the confirmatory testing was negative.

Manufacturer Narrative

Retained devices from the reported lot number were tested with hcg-negative clinical urine samples and cut-off standards (20uiu/ml).The results were read at 3 and 4 minutes and all devices yielded valid negative results with hcg-negative clinical samples.The results were read at 3 minutes for cut-off samples and all devices yielded valid positive results.No false result issues 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.Case details indicate the third test yielded negative results at 3-4 minutes and a positive result at 5 minutes.Per the packet insert, read the result at 3-4 minutes when testing a urine specimen, or at 5-6 minutes when testing a serum specimen.Do not interpret results after the appropriate read time.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 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.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.H3 other text : although requested, the product is not expected to be returned.

• Brand Name: CARDINAL RAPID TEST HCG COMBO
• Type of Device: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9942 mesa rim rd; san diego CA 92121
• Manufacturer Contact: monika burrell ; 9942 mesa rim rd; san diego, CA 92121 ; 8588052506
• MDR Report Key: 16892407
• MDR Text Key: 314816779
• Report Number: 2027969-2023-00033
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20885380020268
• UDI-Public: (01)20885380020268(17)240430(10)HCG2052073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2023

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: 04/30/2024
• Device Model Number: FHC-A202
• Device Catalogue Number: B1077-23
• Device Lot Number: HCG2052073
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female