MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG DIPSTICK TEST; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number FHC-101

Device Problem False Positive Result (1227)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Results pending completion of the investigation.

Event Description

The customer reported receiving two false positive hcg results while using consult hcg dipstick tests.The patient presented for a routine office visit for medication follow up.A fresh urine sample was provided by the customer which yielded 1 negative and 2 positive hcg results.The customer mentioned 3-5 drops of urine was applied to the dipstick and the results were read at 3-4 minutes.Technical services attempted to clarify if drops of urine were applied to the test strip or if the strips were submerged in urine for 5 seconds, however, the customer was unable to clarify.A confirmatory venipuncture sample was collected on the same day which yielded a negative hcg result.No adverse event reported.Please note: according to the package insert, the dipstick should be submerged for 5 seconds.

Manufacturer Narrative

H6 - adverse event problem and h11 - additional mfg narrative updated to include 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 and 4 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 the customer initially mentioned 3-5 drops of urine was applied to the dipstick.Technical services attempted to clarify if drops of urine were applied to the test strip or if the strips were submerged in urine for 5 seconds, however, the customer was unable to clarify.Per the package insert, immerse the test dipstick vertically in the urine specimen for at least 5 seconds.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention product and it is unclear if a deviation occurred.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 specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.- 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.

Event Description

The customer reported receiving two false positive hcg results while using consult hcg dipstick tests.The patient presented for a routine office visit for medication follow up.A fresh urine sample was provided by the customer which yielded 1 negative and 2 positive hcg results.The customer mentioned 3-5 drops of urine was applied to the dipstick and the results were read at 3-4 minutes.Technical services attempted to clarify if drops of urine were applied to the test strip or if the strips were submerged in urine for 5 seconds, however, the customer was unable to clarify.A confirmatory venipuncture sample was collected on the same day which yielded a negative hcg result.No adverse event reported.Please note: according to the package insert, the dipstick should be submerged for 5 seconds.

• Brand Name: CONSULT HCG DIPSTICK TEST
• 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: 19112416
• MDR Text Key: 340811748
• Report Number: 2027969-2024-00046
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202751
• UDI-Public: (01)20612479202751(17)240829(10)0000618208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993203
• 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: 04/25/2024

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-101
• Device Catalogue Number: 5000
• Device Lot Number: 0000618208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2022
• 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 Sex: Female