MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG COMBO CASSETTE (25 MIU/ML); PREGNANCY TEST

Model Number	92225
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting was performed with the customer.Discussed proper testing procedure and limitations per the corresponding package insert: · urine specimens should be allowed to reach room temperature before testing (59-86*f).· very diluted urine specimens (as indicated by low specific gravity) may not contain representative levels of hcg.If pregnancy is 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 suspected, a first-morning urine specimen should be collected 48 hours later and tested.· the hcg product information notice was reviewed which discusses the intended use and limitations of the test.Test provides only 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.Investigation pending.
Event or Problem Description
(b)(6) 2018: patient presented for a colposcopy mid-morning.A negative result was obtained on the alere hcg combo cassette.The colposcopy was performed based on the false negative result.Sometime between 30-60 minutes later, the medical assistant noticed a test line.The urine sample was repeated 2x and a positive result was obtained both times.Blood work was performed the same day and the result was positive at 3310 miu/ml.Although the colposcopy was performed based on the false negative hcg result, the physician states the procedure would have been performed regardless of whether the result was positive.Customer states there was no negative impact to the patient.
Additional Manufacturer Narrative
Investigation conclusion: retention and returned devices for the reported lot were tested with quality control cutoff standard and high hcg clinical urine samples.All devices yielded expected positive results and met quality control release specifications.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Retention and returned devices performed as expected during in-house testing and the reported complaint was not replicated.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: ALERE HCG COMBO CASSETTE (25 MIU/ML)
• Common Device Name: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 8244800
• Report Number: 2027969-2019-00002
• Device Sequence Number: 2126844
• Product Code: JHI
• UDI-Device Identifier: 10815845020116
• UDI-Public: (01)10815845020116(17)190731(10)HCG7080176
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 07/31/2018
• Device Model Number: 92225
• Device Lot Number: HCG7080176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN, DOSAGE AND BRAND NOT PROVIDED.; ORAL CONTRACEPTIVES,DOSAGE/BRAND NOT PROVIDED.; SERTRALINE, DOSAGE NOT PROVIDED; TRAZADONE, DOSAGE NOT PROVIDED.
• Patient Age: 30 YR
• Patient Weight: 62