ABL827
Received Aug 14, 2015 · Event occurred Jul 14, 2015
Report 3002807968-2015-00019 · MDR key 5010562
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DATA LOGS FROM THE ANALYZER HAVE BEEN INVESTIGATED. ALL QC MEASUREMENTS ARE FINE EXCEPT ONE MEASUREMENT ON 07/15/2015 WHICH IS BELOW THE LOWER QC-LIMIT. THERE IS NO SIGN OF DECREASING QC WHICH INDICATES THAT THIS INCIDENT DOES NOT CONCERN THE ISSUE IN THE RECALL WITH RADIOMETER REFERENCE FAN (B)(4) AND FDA REFERENCE: 3002807968-10/29/14-005-R. NO ROOT CAUSE HAVE YET BEEN IDENTIFIED FOR THE LOW QC-RESULT OR FOR THE PATIENT RESULT WHICH WAS REPORTED AS FALSE LOW BY THE CUSTOMER.
Description of Event or Problem
ON (B)(6) 2015 THE CREATININE SENSOR MEMBRANE WAS CHANGED. SUBSEQUENTLY TWO QC CONTROLS WERE RUN WITH AN ACCEPTABLE RESULT AND ACCORDINGLY THE CREATININE ANALYSIS WAS RELEASED. THE NEXT DAY A QC CONTROL WAS RUN WITH A RESULT BELOW THE LOWER ACCEPTANCE LIMIT. THE CUSTOMER REPORTS THAT ON (B)(6) 2015 AFTER RELEASE OF THE CREATININE ANALYSIS, THREE PATIENT RESULTS WERE FALSE LOW AS COMPARED WITH A COBAS ANALYZER. THIS REPORT CONCERNS PATIENT ID (B)(6). THE FOLLOWING TESTS WERE RUN: ANALYZER: COBAS, DATE: (B)(6) 2015, 8:04 AM, RESULT: 250 UMOL/L; COBAS: (B)(6) 2015, 9:13 AM, 259 UMOL/L; ABL827: (B)(6) 2015, 3:31 PM, 178 UMOL/L; ABL827: (B)(6) 2015, 4:38 PM, 170 UMOL/L; ABL827: (B)(6) 2015, 5:25 PM, 145 UMOL/L; COBAS: (B)(6) 2015, 6:30 AM, 200 UMOL/L. THERE WAS NO INJURY, DIAGNOSIS OR TREATMENT BASED ON RESULT FROM THE ABL827.
Additional Manufacturer Narrative
THE ROOT CAUSE TO THIS INCIDENT HAS NOT BEEN IDENTIFIED. THE CUSTOMER HAS INFORMED RADIOMETER THAT CURRENTLY THEY DO NOT SEE ANY PROBLEMS WITH CREA MEASUREMENTS.
Additional Manufacturer Narrative
THE DATE WAS MISSING IN FOLLOW-UP 1 ((B)(6) 2015).