MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT 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 03/20/2024

Event Type  malfunction  

Event Description

The customer reported receiving 3 to 4 false positive hcg results involving an unspecified number of patients while using the consult hcg urine cassettes.Although requested, the customer only provided details regarding one patient.The patient presented for pre-birth control screening.A fresh urine sample was collected, but not allowed to equilibrate to room temperature.Three drops of urine were applied to the test and the results were read "a couple of minutes later".The results were read and a positive hcg result was reported.Confirmatory testing was performed and a negative hcg result was reported.No adverse event reported.Please note: per the package insert: "read the result at 3 minutes." and "allow the test cassette, urine, and/or controls to equilibrate to room temperature (59-86°f/15-30°c) prior to testing.".

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

The customer reported receiving 3 to 4 false positive hcg results involving an unspecified number of patients while using the consult hcg urine cassettes.Although requested, the customer only provided details regarding one patient.The patient presented for pre-birth control screening.A fresh urine sample was collected, but not allowed to equilibrate to room temperature.Three drops of urine were applied to the test and the results were read "a couple of minutes later".The results were read and a positive hcg result was reported.Confirmatory testing was performed and a negative hcg result was reported.No adverse event reported.Technical services advised the customer that a timer should be used and the results should be read at 3 minutes.Technical services attempted to gather specifics on read time, however no further information was provided by the customer.As misuse could not be verified, we are conservatively reporting as a device malfunction.Per the package insert: "read the result at 3 minutes." and "allow the test cassette, urine, and/or controls to equilibrate to room temperature (59-86°f/15-30°c) prior to testing.".

Manufacturer Narrative

B5 - describe event or problem: updated to indicate the customer was advised of the correct read time.D4 - expiration date: updated from blank to 1mar2025 d4 - expiration date null: updated from "ni" to blank as expiration date is being provided.D4 - primary udi number: updated from blank to "((b)(4))".H4 - device mfg date: updated from blank to 3mar2023.H6 - adverse event problem: updated to include completed investigation findings.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded valid 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 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 a timer was not used and the results were read after a couple of minutes.Please note: a timer should be used, and the results should be read at 3 minutes.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: - 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.- 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.- 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 preparation 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 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: 19047711
• MDR Text Key: 339568068
• Report Number: 2027969-2024-00043
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)250301(10)0000694966
• 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
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: 0000694966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2023
• 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 Sex: Female