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 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.H6 - adverse event problem: f28 appropriate term/code not available is being used to capture the delay in the iud procedure.H3 other text : device return has been requested, however a return has not been received yet.

Event Description

The customer reported receiving 4 false positive hcg results while testing 4 patients using 2 lots of consult hcg urine cassettes.The second patient presented on (b)(6) 2024 for a pregnancy test prior to iud insertion.The patient provided a fresh urine sample on both days and no sample appearance issues were noted.The results were read at 3 minutes and false positive hcg results were observed.The iud insertion procedure was rescheduled, and two confirmatory serum beta hcg blood tests were performed on the same days as the urine tests and both tests yielded negative hcg results.No adverse event reported.Although 4 false positive results were reported, the customer provided 5 urine hcg collection timepoints.Therefore 5 mdrs will be reported conservatively.See 2027969-2024-00016, 2027969-2024-00017, 2027969-2024-00019 and 2027969-2024-00020 for related mdrs.

Event Description

The customer reported receiving 4 false positive hcg results while testing 4 patients using 2 lots of consult hcg urine cassettes.The second patient presented on (b)(6) 2024 and on (b)(6) 2024 for a pregnancy test prior to iud insertion.The patient provided a fresh urine sample on both days and no sample appearance issues were noted.The results were read at 3 minutes and false positive hcg results were observed.The iud insertion procedure was rescheduled, and two confirmatory serum beta hcg blood tests were performed on the same days as the urine tests and both tests yielded negative hcg results.No adverse event reported.Although 4 false positive results were reported, the customer provided 5 urine hcg collection timepoints.Therefore 5 mdrs will be reported conservatively.See 2027969-2024-00016, 2027969-2024-00017, 2027969-2024-00019 and 2027969-2024-00020 for related mdrs.

Manufacturer Narrative

D9 - device available for evaluation: was previously reported as "yes", however the customer elected to not return the device(s).H3 - additional text: was updated to remove "yet".H6 - adverse event problem: f28 appropriate term/code not available is being used to capture the delay in the iud procedure.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.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 low levels of hcg (less than 50 mlu/ml) are present in serum and urine specimens 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 serum or urine specimens 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.D4 - serial #: was previously reported as ni, however the correct response is "na" h3 other text : device return has been requested, however a return has not been received.

• 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: 18655892
• MDR Text Key: 334785055
• Report Number: 2027969-2024-00018
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202744
• UDI-Public: (01)20612479202744(17)250525(10)0000719210
• 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,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 0000719210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2023
• 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: 24 YR
• Patient Sex: Female