MAUDE Adverse Event Report: ALERE SAN DIEGO HCG ONE STEP PREGNANCY TEST STRIP (URINE); HCG PREGNANCY TEST

Model Number	FHC-101
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results pending completion of the investigation.
Event or Problem Description
The customer reported that a patient with two at home positive pregnancy tests had a false negative result on an hcg test.An hcg test with a blood sample confirmed pregnancy.
Event or Problem Description
The customer reported that a patient with two at home positive pregnancy tests had a false negative result using an hcg test with a urine sample.An hcg test with a blood sample was sent to a lab confirmed pregnancy, the beta quant was 8646.6 miu/ml.The customer did state the patient was "confused and distressed", but consolable by staff.
Additional Manufacturer Narrative
Additional information: a2: added 29 years old.A4: added 68kg.B5 before :the customer reported that a patient with two at home positive pregnancy tests had a false negative result on an hcg test.An hcg test with a blood sample confirmed pregnancy.B5 now: the customer reported that a patient with two at home positive pregnancy tests had a false negative result using an hcg test with a urine sample.An hcg test with a blood sample was sent to a lab confirmed pregnancy, the beta quant was 8646.6 miu/ml.The customer did state the patient was "confused and distressed", but consolable by staff.B6: added unknown date, beta hcg was 8646.6 miu/ml b7: added lmp 9 weeks before 2/28/2020 (approximately 12/3/19) described as irregular.D10: yes, 04/08/2020.H3: yes.H6: method, added 4101.H6: results, 213.H6: conclusion, 67.Investigation information: retention and returned devices from the reported lot number were tested with cut-off standards (25 miu/ml) and high positive standards (206.17iu/ml, 223.65iu/ml, 229.23iu/ml, and 214.68iu/ml).The 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 from the available information as the reported issue was not replicated during testing of retention product.Per the package, a first morning urine specimen is preferred since it generally contains the highest concentration of hcg; however, urine specimens collected at any time of the day may be used.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.

• Brand Name: HCG ONE STEP PREGNANCY TEST STRIP (URINE)
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO; 9995 summers ridge rd; san diego, ca
• MDR Report Key: 9703045
• Report Number: 2027969-2020-00004
• Device Sequence Number: 12665533
• Product Code: JHI
• Combination Product (Y/N): N
• PMA/510(K) Number: K993203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 08/31/2020
• Device Model Number: FHC-101
• Device Lot Number: HCG8090102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 68