MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. HENRY SCHEIN HCG COMBO 25T; HCG PREGNANCY TEST

Model Number	FHC-202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
The distributor reported the event on behalf of the customer.The patient's last menstrual period was (b)(6) 2018.On (b)(6) 2018, the patient presented at the facility for an iud insertion.A urine sample was collected and a henry schein hcg combo test produced a (b)(6) hcg result.Based on the (b)(6) hcg result, the physician proceeded with the iud insertion.At some point between 7 and 10 minutes, the laboratory observed a faint (b)(6) line had developed on the henry schein hcg combo test.The physician ordered blood work and a serum beta hcg quantitative test produced a result of 49 miu/ml.On (b)(6) 2018, a repeat serum beta hcg quantitative test produced a result of 68 miu/ml.On (b)(6) 2018, the iud was removed from the patient.On (b)(6) 2018, a third serum beta hcg quantitative test produced a result of 87 miu/ml.The patient was subsequently prescribed pre-natal case and no adverse outcomes were reported.Additional serum beta hcg quantitative testing was performed on the patient.On (b)(6) 2018, the patient's hcg was determined to be 366 miu/ml.On (b)(6) 2018, the patient's hcg was determined to be 3037 miu/ml.An ultrasound was also performed on (b)(6) 2018 and revealed a sac with one fetus.The ultrasound indicated that the patients estimated due date is (b)(6) 2019.Troubleshooting was conducted with the customer.The customer was determined to be using non-validated controls (quantimetrix).
Additional Manufacturer Narrative
Retention and returned products were tested with quality control cut-off standard (25 miu/ml hcg urine).All devices produced expected positive results at the read time and met specifications.No false negative results were observed.Review of manufacturing batch records for the reported lot did not uncover any abnormalities and quality control data met specifications.The reported complaint was not replicated during in-house testing as retention and returned products performed as expected.This test is designed for the qualitative detection of hcg in urine or serum to aid in the early detection of pregnancy.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 24-48 hours later and tested.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: HENRY SCHEIN HCG COMBO 25T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7915577
• Report Number: 2027969-2018-00124
• Device Sequence Number: 1514395
• Product Code: JHI
• UDI-Device Identifier: 10304040024123
• UDI-Public: (01)10304040024123(17)200430(10)HCG8050024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: FHC-202
• Device Catalogue Number: 9004075
• Device Lot Number: HCG8050024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 31 YR