N ANTISERUM TO HUMAN IGM
Received Sep 1, 2017 · Event occurred Aug 1, 2017
Report 9610806-2017-00096 · MDR key 6840149
Device
Generic name
N Antiserum To Human Igm
Manufacturer
Siemens Healthcare Diagnostics Products GmbhModel number
N ANTISERUM TO HUMAN IGMCatalog number
10446303
Lot number
153226F
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO DETERMINE THE CAUSE OF THE DIFFERENT IGM RESULTS OBTAINED THE PATIENT SAMPLE ON THE BN II SYSTEM AND FOUND NO ISSUES. SIMILAR RESULTS WERE OBTAINED ON BOTH SYSTEMS AND THE INTERNAL QUALITY CONTROLS RECOVERED WITHIN RANGE, INDICATING A SAMPLE ISSUE. THE CUSTOMER AGREED THAT THIS ISSUE IS SAMPLE SPECIFIC. THE CUSTOMER REPORTED THAT THEY HAVE NOT RECEIVED ANY COMPLAINTS FROM ANY PHYSICIANS. THE CUSTOMER POWERED DOWN THE SYSTEM SINCE THE ORIGINAL PATIENT SAMPLES WERE RUN AND THE KINETICS AND ORIGINAL PATIENT SAMPLE WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. THE INSTRUMENTS AND REAGENTS ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.
Description of Event or Problem
A FLAGGED HIGH IMMUNOGLOBULIN M (IGM) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE BN II SYSTEM. THE SAME PATIENT SAMPLE WAS DILUTED USING MULTIPLE DILUTION RATIOS AND RUN ON THE SAME BN II SYSTEM. DIFFERENT IGM RESULTS WERE OBTAINED ON THESE SAMPLES AND THE RESULTS WERE DILUTION RATIO DEPENDENT. THE SAME PATIENT SAMPLE WAS RESPUN AND RUN WITH MULTIPLE DILUTIONS ON AN ALTERNATE BN II SYSTEM. THE RESULTS OBTAINED ON THE ALTERNATE BN II SYSTEM MATCHED THE RESULTS OBTAINED ON THE ORIGINAL SYSTEM. AN IGM RESULT OF 508.0 MG/DL WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED THAT THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN SINCE THEY DO NOT HAVE THE PATIENT'S CLINICAL HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FLAGGED HIGH IGM RESULT ON THIS PATIENT SAMPLE.