MAUDE Adverse Event Report: FISHER SCIENTIFIC COMPANY L.L.C. SURE-VUE; VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number 23900531

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Abdominal Pain (1685)

Event Date 06/04/2021

Event Type  malfunction  

Event Description

Patient arrived to the ed for abdominal pain.Urine hcg test was ordered and resulted.Urine hcg was positive.Ct findings indicate that patient had a hysterectomy.

• Brand Name: SURE-VUE
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): FISHER SCIENTIFIC COMPANY L.L.C.; 168 third avenue; waltham MA 02451
• MDR Report Key: 12127601
• MDR Text Key: 260263171
• Report Number: 12127601
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23900531
• Device Lot Number: HCG0122044
• 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: 06/18/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Weight: 48