inforMED
MalfunctionMLM

DIMENSION®

Received Apr 26, 2019 · Event occurred Mar 15, 2019

Report 2517506-2019-00181 · MDR key 8555375

Device

Generic name

Dimension® Tacrolimus Flex® Reagent Cartridge

Catalog number

DF207 SMN 10700795

Lot number

GA9267

Product problems

  • Low Test Results
  • Low Test Results

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

MDR 2517506-2019-00182 WAS FILED FOR THE SAME EVENT. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED A DISCORDANT DEPRESSED TACROLIMUS (TAC) PATIENT RESULT OBTAINED ON THE DIMENSION EXL WITH LM INSTRUMENT. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

A DISCORDANT DEPRESSED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN (S). A DILUTED SAMPLE FROM THE SAME PATIENT WAS PROCESSED WITH THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED TAC RESULT.

Additional Manufacturer Narrative

INITIAL MDR 2517506-2019-00181 WAS FILED ON 26-APR-2019. ADDITIONAL INFORMATION (09-MAY-2019): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) RESULT. HSC HAS REVIEWED THE INFORMATION PROVIDED. IT IS STATED IN THE INSTRUCTIONS FOR USE (IFU) FOR TAC THAT CERTAIN MEDICATIONS "MAY INCREASE OR DECREASE BLOOD LEVELS OF TACROLIMUS" ON DIMENSION EXL. THE ANTIBIOTIC THE PATIENT WAS TAKING, RIFAMPICIN (RIFAMPIN), IS LISTED AS A DRUG THAT CAN DECREASE TAC RESULTS. THE CUSTOMER STATED THAT THE PATIENT SAMPLE WAS PROCESSED ON AN ALTERNATE TECHNOLOGY WHICH ALSO GAVE RESULTS LOWER THAN PHYSICIAN EXPECTATIONS WHILE THE PATIENT WAS UNDER ANTIBIOTIC THERAPY. THE CUSTOMER STATED THAT WHEN THE DOCTOR SUSPENDED THE ADMINISTRATION OF THE ANTIBIOTICS AND A NEW SAMPLE WAS OBTAINED, THE RESULTS OBTAINED ON THE DIMENSION FOR TAC WERE HIGHER, CONSISTENT WITH PHYSICIAN EXPECTATIONS. HSC REQUESTED ADDITIONAL DATA IN ORDER TO PERFORM FURTHER INVESTIGATION HOWEVER THIS DATA WAS NOT PROVIDED. THE CAUSE OF THIS EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION SUPPLEMENTAL MDR 2517506-2019-00182 WAS FILED FOR THE SAME EVENT.