MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. SURESTEP HCG URINE CASSETTE (25T); PREGNANCY TEST

Model Number FHC-102

Device Problem False Negative Result (1225)

Patient Problem Ectopic Pregnancy (1819)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event Description

On (b)(6) 2018: patient visited (b)(6) infirmary for an unspecified reason.A serum beta hcg was performed and the result was 865 miu/ml.On (b)(6) 2018: patient presented to (b)(6) facility at the request of (b)(6) infirmary to have a urine test and scan performed.A urine test was performed on the surestep hcg test and the result was negative.No scan was performed due to negative result on the rapid test.On (b)(6) 2018: patient presented to (b)(6) with abdominal pain.Beta quant=465 miu/ml.Scan was performed which showed a ruptured ectopic pregnancy.The patient required a laparotomy where the patient lost approximately 1 litre of blood and a fallopian tube.Customer states if result on the surestep hcg test performed on (b)(6) would have been positive, the ectopic pregnancy could have been managed as a non-emergent surgery.

Manufacturer Narrative

Investigation conclusion: retention products for the reported lot number were tested with qc cut-off hcg standard and middle positive hcg standard.All devices yielded correct positive results at the read time.No false negative results were observed.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.The reported complaint for a false negative hcg result was not replicated as retention products performed as expected.A root cause could not be determined based on the information provided.Per the package insert, this test may produce false negative results.False negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.

• Brand Name: SURESTEP HCG URINE CASSETTE (25T)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 8249081
• MDR Text Key: 133109595
• Report Number: 2027969-2019-00004
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FHC-102
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 28 YR