N LATEX FLC KAPPA
Received Nov 12, 2021 · Event occurred Oct 5, 2021
Report 9610806-2021-00069 · MDR key 12802833
Device
Generic name
N Latex Flc Kappa
Manufacturer
Siemens Healthcare Diagnostics Products GmbhModel number
N LATEX FLC KAPPACatalog number
10482437
Lot number
473159A
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC KAPPA REAGENT USING A 1:100 SAMPLE DILUTION. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR FLC KAPPA USING A 1:400 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REPEATED FOR FLC KAPPA USING A 1:2000 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REPEATED AGAIN FOR FLC KAPPA USING A 1:400 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE HIGHER REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC KAPPA RESULT.
Additional Manufacturer Narrative
AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROL (QC) DATA WAS NOT PROVIDED BY THE CUSTOMER. NO SYSTEM OR REAGENT ABNORMALITIES WERE IDENTIFIED. THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.
Description of Event or Problem
A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA NEPH 630 SYSTEM USING N LATEX FLC KAPPA REAGENT USING A 1:100 SAMPLE DILUTION. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR FLC KAPPA USING A 1:400 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REPEATED FOR FLC KAPPA USING A 1:2000 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE SAMPLE WAS THEN REPEATED AGAIN FOR FLC KAPPA USING A 1:400 DILUTION, RECOVERING HIGHER THAN THE INITIAL RESULT. THE HIGHER REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC KAPPA RESULT.
Additional Manufacturer Narrative
AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROL (QC) DATA WAS NOT PROVIDED BY THE CUSTOMER. NO SYSTEM OR REAGENT ABNORMALITIES WERE IDENTIFIED. THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.