MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT DIAGNOSTICS HCG URINE CASSETTE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-A102

Device Problem False Positive Result (1227)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

Conclusion pending completion of investigation.H3 other text : although requested, the product has not been received.

Event Description

The customer reported a total of six false positive results when testing five patients using the consult diagnostics hcg urine cassette from two different lots.Patient pat-004291 was being tested prior to an unspecified procedure.The patient provided a fresh urine sample which was tested using lot 0000679523 and yielded a false positive result.A blood sample was collected the same day and a beta-hcg test was performed with a negative result (quantitative value not provided).The unspecified procedure was rescheduled, and there were no adverse patient outcomes reported.See mdrs 2027969-2023-00122, 2027969-2023-00123, and 2027969-2023-00125 for the other false positive results with lot 0000679523.See mdrs 2027969-2023-00126 and 2027969-2023-00127 for the false positive results with lot 0000700579.

Event Description

The customer reported a total of six false positive results when testing five patients using the consult diagnostics hcg urine cassette from two different lots.Patient (b)(6) was being tested prior to an unspecified procedure (the customer stated that the patients were being screened prior iud insertions or colposcopies, but did not specify which procedure each patient was to undergo).The patient provided a fresh urine sample which was tested using lot 0000679523 and yielded a false positive result.A blood sample was collected the same day and a beta-hcg test was performed with a negative result (quantitative value not provided).The unspecified procedure was rescheduled, and there were no adverse patient outcomes reported.See mdrs 2027969-2023-00122, 2027969-2023-00123, and 2027969-2023-00125 for the other false positive results with lot 0000679523.See mdrs 2027969-2023-00126 and 2027969-2023-00127 for the false positive results with lot 0000700579.

Manufacturer Narrative

D9 updated to reflect receipt of returned product on 02-jan-2024.H6 updated to reflect testing of returned product.Investigation conclusion: retained and returned devices from the reported lot numbers were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded the expected negative results.No false positive 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 lots 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: ¿ very low levels of hcg (less than 50 miu/ml) are present in 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 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 urine 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: CONSULT DIAGNOSTICS HCG URINE CASSETTE
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• 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: 18387418
• MDR Text Key: 331504266
• Report Number: 2027969-2023-00124
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)250207(10)0000679523
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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 Model Number: FHC-A102
• Device Catalogue Number: 5001
• Device Lot Number: 0000679523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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: 45 YR
• Patient Sex: Female