CLINITEK STATUS+
Received Apr 26, 2023 · Event occurred Mar 24, 2023
Report 3002637618-2023-00024 · MDR key 16820048
Device
Generic name
Method, Enzymatic, Glucose (urinary, Non-quantitative)
Manufacturer
Siemens Healthcare Diagnostics Inc.Catalog number
10379680
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MANUFACTURER HAS COMPLETED THE INVESTIGAITON: RETAIN SAMPLES AND DESIGN HISTORY RECORDS FROM PRODUCTION PROCESSES (LAMINATION AND SLIT/FILL/CAP) WERE CHECKED. ALL IN PROCESS CHECKS WERE PERFORMED AND WERE POSITIVE. RETAIN SAMPLES REVIEW WAS POSITIVE, NO ISSUES WERE OBSERVED. THE IN-PROCESS CONTROL (100% CARD CONTROL) WAS NOT ABLE TO DETECT ONE CARD WITHOUT A SMALL FRAGMENT OF COMPONENT MISSING (CA. 1,6 INCH). A QUALITY ALERT ((B)(6)) AS WELL AS RETRAINING OF OPERATORS FROM CARD CONTROL INSTRUCTION ((B)(4) WERE PROVIDED TO INCREASE OPERATORS' AWARENESS OF THE PROBLEM. THE PERCENTAGE OF RIP-OFF DURING PRODUCTION IS LOW AND FITS WITHIN PREARRANGED SUPPLIER ¿ CUSTOMER AGREEMENT. NO SYSTEMIC PRODUCT PROBLEM. ROOT CAUSE IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER PERFORMED A URINE STRIP TEST ON THEIR CLINITEK STATUS+ USING URO-HEMA-COMBISTIX. THE URINE STRIP WAS MISIDENTIFIED AS LABSTIX SG AND THE ANALYZER PRODUCED A RESULT ON THE PATIENT SAMPLE. INSPECTION OF THE STRIP, FOUND THAT THE ID BAND, WHICH THE INSTRUMENT USES TO IDENTIFY STRIP TYPE, WAS MISSING. A NEW STRIP WAS USED AND THE CORRECT STRIP TYPE WAS IDENTIFIED BY THE INSTRUMENT AND CORRECT RESULTS REPORTED. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION IS UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN.