inforMED
MalfunctionGKL

ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC

Received Dec 20, 2022 · Event occurred Nov 24, 2022

Report 2432235-2022-00394 · MDR key 16018332

Device

Generic name

Advia 120/2120/2120i Cn-free Cbc Timepac

Catalog number

10341169

Lot number

18367

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

Description of Event or Problem

THE CUSTOMER OBSERVED TINY BLACK PARTICLES IN THE HEMOGLOBIN (HGB) REAGENT OF THE ADVIA 120/2120/2120I CYANIDE FREE COMPLETE BLOOD COUNT TIMEPAC (ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC), LOT: 18367. NONE OF THE OTHER REAGENTS IN THE ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC HAVE THE PARTICLES. THE CUSTOMER INDICATED THAT INCORRECT HGB RESULTS MAY HAVE BEEN OBTAINED DUE TO THIS ISSUE, BUT NO PATIENT DATA WAS PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER REPORTED AN INCREASED INCIDENCE OF QUALITY CONTROLS (QC) FOR HEMOGLOBIN RECOVERING OUT OF RANGE FOR NORMAL QC. SIEMENS IS INVESTIGATING THE ISSUE. MDRS 2432235-2022-00393 AND 2432235-2022-00395 WERE FILED FOR LOTS: 65597 AND 36380 OF THE ADVIA 120/2120/2120I CN-FREE CBC TIMEPAC REAGENT, RESPECTIVELY.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2023-00394 ON 20-DEC-2022. ADDITIONAL INFORMATION (08-JUN-2023): THE INITIAL REPORT WAS CONSERVATIVELY FILED DUE TO THE CUSTOMER'S ALLEGATION OF POTENTIAL ERRONEOUS HEMOGLOBIN RESULTS DUE TO BLACK PARTICLES IN THE HEMOGLOBIN REAGENT. HOWEVER, AT THE TIME OF FILING, THE CUSTOMER DID NOT PROVIDE PATIENT RESULTS; AT THAT TIME, THE CUSTOMER PROVIDED EXAMPLES OF OUT-OF-RANGE QUALITY CONTROLS. SIEMENS FURTHER INVESTIGATED THE ISSUE AND DETERMINED THAT THE PARTICLES HAVE A PORE SIZE OF LESS THAN 105 MICRONS AND DOES NOT IMPACT PATIENT RESULTS NOR QUALITY CONTROLS. ADDITIONALLY, THESE PARTICLES WOULD NOT BLOCK ANY TUBES OR APERTURES IN THE SYSTEM AND WOULD FLOW THROUGH THE SYSTEM AND INTO THE WASTE CHAMBER. PARTICLES COULD POTENTIALLY ACCUMULATE OVER TIME AT JUNCTION POINTS IN THE FLUIDICS CIRCUIT. IN THE EVENT THAT PARTICLES ACCUMULATE AND RESULTS ARE PRODUCED, THE SYSTEM WOULD FLAG RESULTS WITH HGB IRREGULAR FLOW RATE (HGBIFR, HR), MAKING THIS APPARENT TO THE OPERATOR. SUPPLEMENTAL MDRS 2432235-2022-00393_S1 AND 2432235-2022-00395_S1 WERE ALSO FILED FOR THE ADDITIONAL INFORMATION.