MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE HCG CASSETTE; RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN

Lot Number HCG7040129;HCG7070005

Device Problems False Negative Result (1225); False Positive Result (1227)

Patient Problem Abdominal Pain (1685)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

Several incidents reported of inaccurate point-of-collection testing (poct) urine human chorionic gonadotropin (hcg) tests-false positives and negatives with poc pregnancy testing.An ed patient who had a false negative poct urine test approximately one week ago, underwent a ct scan of her abdomen with contrast and 2 ultrasound tests.Based on the ct scan/us findings, an hcg serum quantitative blood test was performed and results came back at positive level.The products were pulled off the shelf post event from all our facilities.Excerpt from emr ".Female.Presents to the emergency department with complaint of severe right-sided abdominal pain.The patient's original testing came back with a negative pregnancy test.Ultrasound showed what looks like possible corpus luteal cyst in the right side and possible iup* but would be very early if true.The patient had negative pregnancy test therefore ct scan was obtained to evaluate for an appendicitis given her continued pain.Ct scan was unremarkable.The patient was discussed with the obgyn physician who recommended a serum hcg because of the recent event of a negative hcg.They came out positive on blood.Blood test was ordered which came back with a positive pregnancy test with an hcg of 1312" * intrauterine pregnancy.

Event Description

Several incidents reported of inaccurate point-of-collection testing (poct) urine human chorionic gonadotropin (hcg) tests-false positives and negatives with poc pregnancy testing.An ed patient who had a false negative poct urine test approximately one week ago, underwent a ct scan of her abdomen with contrast and 2 ultrasound tests.Based on the ct scan/us findings, an hcg serum quantitative blood test was performed and results came back at positive level.The products were pulled off the shelf post event from all our facilities.Excerpt from emr ".Female.Presents to the emergency department with complaint of severe right-sided abdominal pain.The patient's original testing came back with a negative pregnancy test.Ultrasound showed what looks like possible corpus luteal cyst in the right side and possible iup* but would be very early if true.The patient had negative pregnancy test therefore ct scan was obtained to evaluate for an appendicitis given her continued pain.Ct scan was unremarkable.The patient was discussed with the obgyn physician who recommended a serum hcg because of the recent event of a negative hcg.They came out positive on blood.Blood test was ordered which came back with a positive pregnancy test with an hcg of 1312" * intrauterine pregnancy.

• Brand Name: ALERE HCG CASSETTE
• Type of Device: RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 7057361
• MDR Text Key: 92873286
• Report Number: 7057361
• Device Sequence Number: 0
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: HCG7040129;HCG7070005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 60