MAUDE Adverse Event Report: STANBIO LABORATORY, L.P. QUPID® HCG; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number 1220-050

Device Problem False Negative Result (1225)

Patient Problem Pregnancy (3193)

Event Date 06/06/2018

Event Type  malfunction  

Event Description

Patient scheduled appointment for removal and reinsertion of an intrauterine device (iud).Per protocol, pregnancy test conducted.At the 3 minute (timed) moment per manufacturer instructions, the test was checked for sign of positive.Both nurse and provider confirmed test was negative.Medical assistant at approximately the 6-7 min point saw a positive, informed the provider and decision made to do a second test prior to insertion.Second test confirmed positive at 3 min.Quant human chorionic gonadotropin (hcg) also came back at 40.Manufacturer guidance states sensitive to hcg of 20.Interviewing of staff noted that "yes, we have seen delays lately, with positive showing not till 4-5 min.".

Event Description

Patient scheduled appointment for removal and reinsertion of an intrauterine device (iud).Per protocol, pregnancy test conducted.At the 3 minute (timed) moment per manufacturer instructions, the test was checked for sign of positive.Both nurse and provider confirmed test was negative.Medical assistant at approximately the 6-7 min point saw a positive, informed the provider and decision made to do a second test prior to insertion.Second test confirmed positive at 3 min.Quant human chorionic gonadotropin (hcg) also came back at 40.Manufacturer guidance states sensitive to hcg of 20.Interviewing of staff noted that "yes, we have seen delays lately, with positive showing not till 4-5 min.".

• Brand Name: QUPID® HCG
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): STANBIO LABORATORY, L.P.; 1261 n main st; boerne TX 78006
• MDR Report Key: 7649880
• MDR Text Key: 112714955
• Report Number: 7649880
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1220-050
• Device Catalogue Number: 1220-050
• Device Lot Number: 180221-556
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2018
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Weight: 73