MAUDE Adverse Event Report: ALERE SAN DIEGO ALERE HCG CASSETTE 30T; HCG PREGNANCY KIT

Model Number	FHC-A102
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of investigation.
Event or Problem Description
It was reported that a patient who had 4 positive at home pregnancy test results was tested at the clinic on the hcg cassette with a negative result.The patient was set to start melatonin but it was withheld due to the result on the hcg cassette she returned home, administered another at home pregnancy test which was positive again.The patient then returned to the clinic, had a false negative result again with a confirmatory lab serum quant of 125 miu/ml.Troubleshooting occurred with a discussion about the false negative event and possible causes such as technique, storage, handling, and specimen factors per package insert.
Additional Manufacturer Narrative
A2: age 20 years.B5: event: no adverse patient outcome.Patient is continuing with the pregnancy.B6: relevant tests/laboratory data on 7/31/2019: alere hcg cassette result, negative at 3 minutes, serum beta quant, 38.5 miu/ml on (b)(6) 2019: alere hcg cassette result, negative at 3 minutes, faint line at 4 minutes, serum beta quant, 125.7 miu/ml.B7: other relevant history: last menstrual period approximately on (b)(6) 2019.Investigation conclusion: retention devices from the reported lot number were tested with cut-off standard (20 miu/ml) and middle positive standard (100 miu/ml).Results were read at 3 minutes and all devices yielded the expected positive results.No false negative 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 as the reported complaint was not replicated during testing of retention devices.However, 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.A first morning urine specimen is preferred since it generally contains the highest concentration of hcg.
Event or Problem Description
No adverse patient outcome.Patient is continuing with the pregnancy.

• Brand Name: ALERE HCG CASSETTE 30T
• Common Device Name: HCG PREGNANCY KIT
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego CA 92121
• MDR Report Key: 8919079
• Report Number: 2027969-2019-00211
• Device Sequence Number: 13953293
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)210228(10)HCG9030081
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 02/28/2021
• Device Model Number: FHC-A102
• Device Lot Number: HCG9030081
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR