MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER SURE-VUE HCG URINE DIPSTICK; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number	FHC-111
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of the investigation.H3 other text : although requested, device return is not anticipated.
Event or Problem Description
The customer reported receiving a total of four false positive hcg results on the sure-vue hcg urine test for four patients.The four patients were tested in an infertility clinic and the customer reported noted 3 false positive results on lot hcg2042082 and 1 on lot hcg2042074.A fresh urine sample was provided in each instance and the samples appeared "normal".The customer indicated the test was performed according to the package insert and the results were read at 4 minutes.Repeat tests with the same kits were performed for all four patients and negative results were obtained.No adverse event reported.See mdr 2027969-2023-00108 and 2027969-2023-00109 for additional false positive results on lot hcg2042082 and mdr 2027969-2023-00110 for the reported false positive on lot hcg2042074.
Event or Problem Description
The customer reported receiving a total of four false positive hcg results on the sure-vue hcg urine test for four patients.The four patients were tested in an infertility clinic and the customer reported noted 3 false positive results on lot hcg2042082 and 1 on lot hcg2042074.A fresh urine sample was provided in each instance and the samples appeared "normal".The customer indicated the test was performed according to the package insert and the results were read at 4 minutes.Repeat tests with the same kits were performed for all four patients and negative results were obtained.No adverse event reported.See mdr 2027969-2023-00109 and 2027969-2023-00110 for additional false positive results on lot hcg2042082 and mdr 2027969-2023-00108 for the reported false positive on lot hcg2042074.
Additional Manufacturer Narrative
Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine and 25 miu/ml cut-off urine samples.The results were read at 3 and 4 minutes for devices tested with hcg-negative clinical urine and all devices yielded valid negative results.The results were read at 3 minutes for devices tested with cut-off samples and all devices yielded valid positive results.No false 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 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 nontrophoblastic 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.H6 - adverse event problem: updated as investigation completed.H10 - additional mfg narrative: updated as investigation completed.D4 - model #: previously reported as fhc-101.Correct information is fhc-111.H3 other text : although requested, device return is not anticipated.
Additional Manufacturer Narrative
Results pending completion of the investigation.B5 - describe event or problem: updated to "see mdr 2027969-2023-00109 and 2027969-2023-00110 for additional false positive results on lot hcg2042082 and mdr 2027969-2023-00108 for the reported false positive on lot hcg2042074." h3 other text : although requested, device return is not anticipated.
Event or Problem Description
The customer reported receiving a total of four false positive hcg results on the sure-vue hcg urine test for four patients.The four patients were tested in an infertility clinic and the customer reported noted 3 false positive results on lot hcg2042082 and 1 on lot hcg2042074.A fresh urine sample was provided in each instance and the samples appeared "normal".The customer indicated the test was performed according to the package insert and the results were read at 4 minutes.Repeat tests with the same kits were performed for all four patients and negative results were obtained.No adverse event reported.See mdr 2027969-2023-00109 and 2027969-2023-00110 for additional false positive results on lot hcg2042082 and mdr 2027969-2023-00108 for the reported false positive on lot hcg2042074.

• Brand Name: FISHER SURE-VUE HCG URINE DIPSTICK
• Common Device Name: 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: 18134237
• Report Number: 2027969-2023-00107
• Device Sequence Number: 7753362
• Product Code: JHI
• UDI-Device Identifier: 00613647000588
• UDI-Public: (01)00613647000588(17)240430(10)HCG2042082
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K993203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: FHC-111
• Device Catalogue Number: 23900527
• Device Lot Number: HCG2042082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 11/20/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 11/14/2023; 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female