MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. CONSULT HCG DIPSTICK TEST 5000 25T; PREGNANCY TEST

Model Number FHC-101

Device Problem False Positive Result (1227)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation.

Event Description

(b)(6) 2020: patient presented to the facility for a colonoscopy.A false positive result was obtained 1x on the consult diagnostics hcg dipstick kit.Patient disagreed with result as husband had a vasectomy 8 years ago.Confirmatory serum quant provided a negative result of <1 miu/ml.(b)(6) 2020: a second serum quant was performed on (b)(6) 2020 and a second negative result of <1 miu/ml was obtained.(b)(6) 2020: a urine specimen was performed on the alere hcg urine cassette and the correct negative result was obtained.Procedure was delayed based on the false positive result obtained on (b)(6) 2020 and was rescheduled for (b)(6) 2020.Procedure was non-emergent.No adverse outcomes reported.A false positive result was also obtained on a second lot for this patient (see mdr 2027969-2020-00087).

Manufacturer Narrative

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 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 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.Review of the information provided did not identify any deviations from the package insert.A root cause could not be determined 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, 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 DIPSTICK TEST 5000 25T
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 11013093
• MDR Text Key: 240737790
• Report Number: 2027969-2020-00088
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 20612479202751
• UDI-Public: (01)20612479202751(17)220331(10)HCG0042092
• Combination Product (y/n): N
• PMA/PMN Number: K993203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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: 03/31/2022
• Device Model Number: FHC-101
• Device Lot Number: HCG0042092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALPARZOLAM; CULTURELLE PROBIOTIC; TOPIRAMATE; TYLENOL W/ CODEINE
• Patient Outcome(s): Life Threatening
• Patient Age: 45 YR
• Patient Weight: 77