MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE (20MIU/ML) 30T; HCG PREGNANCY TEST

Model Number	92210
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Menstrual Irregularities (1959)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
The patient previously received a positive result using a home pregnancy test.On (b)(6) 2018, the patient was tested at the facility to confirm the result of the home pregnancy test.A urine sample was collected and produced a negative result using an alere hcg cassette.The patient was instructed to follow up with her physician or return for a retest.On (b)(6) 2018, the patient arrived at the emergency room presenting with bleeding and pain.An ultrasound was conducted and confirmed the pregnancy.The patient was determined to be five weeks pregnant.The patient was later discharged from the emergency room without further bleeding or pain.The customer stated a first-morning sample is typically not used.Troubleshooting was conducted with the customer.The customer was advised that very diluted urine specimens (as indicated by low specific gravity) may not contain representative levels of hcg.Additionally, 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.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.
Additional Manufacturer Narrative
Returned product was not received.Retention devices were tested in-house with a qc cut-off hcg standard.All devices showed the correct positive results at the read time and met qc specifications.No false negative results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The quantity of urine hcg levels may be low in the early stages of pregnancy.Urine samples are more likely influenced by many factors (such as take in too much water or renal dysfunction) which will dilute the urine sample.Per pi, 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.Because the specimen associated with the complaint was not returned for investigation, a root cause could not be determined based on the information provided.Based on the information available, there is no indication of a product deficiency and no corrective action is required.(report source) corrected to remove company representative and include consumer.
Additional Manufacturer Narrative
Investigation conclusion: returned and retention devices were tested in-house with a qc cut-off hcg standard.All devices showed the correct positive results at the read time and met qc specifications.No false negative results were obtained during in-house testing.The product performed as expected.Manufacturing batch record review did not uncover any abnormalities.The quantity of urine hcg levels may be low in the early stages of pregnancy.Urine samples are more likely influenced by many factors (such as take in too much water or renal dysfunction) which will dilute the urine sample.Per pi, 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.Because the specimen associated with the complaint was not returned for investigation, a root cause could not be determined based on the information provided.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: ALERE HCG CASSETTE (20MIU/ML) 30T
• Common Device Name: HCG PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7378741
• Report Number: 2027969-2018-00033
• Device Sequence Number: 1263887
• Product Code: JHI
• UDI-Device Identifier: 10815845020130
• UDI-Public: (01)10815845020130(17)190930(10)HCG7090141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2018

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: 09/30/2019
• Device Model Number: 92210
• Device Lot Number: HCG7090141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 04/27/2018; 05/14/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/02/2018; 05/29/2018
• 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: Other
• Patient Age: 26 YR