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

Model Number FHC-A202

Device Problem False Negative Result (1225)

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

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

B3 - date of event: the date of event was not provided; however the article indicated the results were obtained between 1sep2017 and 31aug2018.Investigation conclusion: 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 and retain device testing could not be performed as a lot number was not provided.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 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.- false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning serum or urine specimen should be collected 48 hours later and tested.- this test reliably detects intact hcg up to 500,000 miu/ml.It does not reliably detect hcg degradation products, including free-beta hcg and beta core fragments.Quantitative assays used to detect hcg may detect hcg degradation products and therefore may disagree with the results of this rapid test.- 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.H3 other text : device return is not anticipated.

Event Description

Review of the article "false-negative urine human chorionic gonadotropin testing in the clinical laboratory" noted false negative hcg results for multiple patients while using the sure-vue stat serum/urine hcg test.The tenth patient mentioned presented with fatigue, sore throat, and a cough.Testing with a urine sample on the sure-vue stat serum/urine hcg test yielded a negative result.Sixteen days later the patient had a serum hcg test performed which yielded a positive result of 5,579 miu/ml.The patient was believed to have an estimated gestational age of 2-3 weeks when the negative hcg result was obtained.As a result of the initial negative hcg result, the patient underwent a chest x-ray procedure.No further information was provided.Please see mdr 2027969-2024-00024, 2027969-2024-00025, 2027969-2024-00026, 2027969-2024-00027, 2027969-2024-00028, 2027969-2024-00029, 2027969-2024-00030, 2027969-2024-00031, 2027969-2024-00032, 2027969-2024-00034, 2027969-2024-00035 for related events.

• Brand Name: FISHER SURE-VUE HCG STAT SERUM/URINE
• 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: 18763296
• MDR Text Key: 336055275
• Report Number: 2027969-2024-00033
• Device Sequence Number: 1
• Product Code: JHI
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female