inforMED
MalfunctionGGP

BERICHROM PROTEIN C

Received Dec 21, 2018 · Event occurred Nov 16, 2018

Report 9610806-2018-00116 · MDR key 8189356

Device

Generic name

Berichrom Protein C

Catalog number

10446499

Lot number

48671

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT DIFFERENT PROTEIN C RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES USING THE BERICHROM PROTEIN C REAGENT. SIEMENS REVIEWED THE SYSMEX CS-5100 SYSTEM BACK UP FILES AND DETERMINED THAT THE CUSTOMER IS NOT USING THE MOST RECENT BERICHROM PROTEIN C APPLICATION ON THE SYSMEX CS-5100 SYSTEM. THE SOFTWARE APPLICATION USED BY THE CUSTOMER MAY NOT FEATURE RE-DILUTION AND IT IS POSSIBLE THAT THE CUSTOMER MANUALLY DILUTED THE SAMPLES PRIOR TO REPEATING THE SAMPLES. THERE IS NO INDICATION OF A SOFTWARE OR REAGENT MALFUNCTION AND SIEMENS DETERMINED THAT AN ISSUE WITH THE MANUAL DILUTION OF THE SAMPLES POTENTIALLY CONTRIBUTED TO THE DIFFERENT PROTEIN C RESULTS. THE SYSMEX CS-5100 SYSTEM INSTRUCTIONS FOR USE INDICATES THAT WHEN RESULTS ARE FLAGGED WITH ERROR CODE 0000.4000.0041 [EXTRAPOLATION BOUNDARY OVER (UPPER)], THE OPERATOR SHOULD CHANGE THE DILUTION RATIO AND REPEAT THE ANALYSIS. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2018-00117 WAS FILED FOR THE RESULT OBTAINED ON (B)(6) 2018 FOR SAMPLE ID (B)(6).

Description of Event or Problem

FLAGGED NON-NUMERICAL PROTEIN C RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM, USING THE BERICHROM PROTEIN C REAGENT. THE FLAGGED RESULT FOR SAMPLE ID (B)(6) WAS REPORTED TO THE PHYSICIAN(S), AND IT IS UNKNOWN IF THE FLAGGED RESULT FOR SAMPLE ID (B)(6) WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE DILUTED IN A 1:4 DILUTION AND REPEATED ON THE SAME SYSTEM, USING THE SAME REAGENT LOT, RESULTING IN NUMERICAL PROTEIN C RESULTS. THE REPEAT RESULT FOR SAMPLE ID (B)(6) WAS REPORTED TO THE PHYSICIAN(S). ON (B)(6) 2018, SAMPLE ID (B)(6) WAS REPEATED AGAIN ON THE SAME SYSTEM AND REAGENT LOT, RESULTING HIGHER THAN THE REPEAT RESULT. THE CORRECT RESULT FOR EITHER PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT PROTEIN C RESULTS.