inforMED
MalfunctionMLM

DIMENSION

Received Mar 11, 2020 · Event occurred Feb 19, 2020

Report 2517506-2020-00099 · MDR key 9819534

Device

Generic name

Dimension® Tac Tacrolimus Flex® Reagent Cartridge

Model number

10700795

Catalog number

DF207 SMN 10700795

Lot number

GE0260

Product problems

  • High Test Results
  • High Test Results

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

MDR 2517506-2020-00099 WAS FILED ON 11-MAR-2020. ADDITIONAL INFORMATION (05-MAY-2020): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THEIR INVESTIGATION OF THE DISCORDANT ELEVATED TACROLIMUS (TAC) RESULT ON A DIMENSION EXL SYSTEM. THE CUSTOMER PROVIDED ADDITIONAL DATA REGARDING SAMPLES TESTED FROM THE SAME PATIENT ON LATER DATES. RESULTS WERE AS FOLLOWS: SAMPLE ID 5349087 DATE 2020/03/09 RESULT ON NON-SIEMENS SYSTEM 7.4 NG/ML; DIMENSION :16.1 NG/ML. SAMPLE ID 5353095 DATE 2020/03/13 RESULT ON NON-SIEMENS SYSTEM 7.3 NG/ML; DIMENSION: 18.1 NG/ML. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) HAS REVIEWED THE INFORMATION PROVIDED. HSC RECOMMENDED MAINTENANCE BE PERFORMED ON THE INSTRUMENT. IT IS UNKNOWN IF THE MAINTENANCE HSC SUGGESTED WAS PERFORMED BY THE CUSTOMER. IN ADDITION, HSC REQUESTED INFORMATION ABOUT OTHER MEDICATIONS THIS PATIENT WAS TAKING DURING THE TIME OF TESTING HOWEVER THAT INFORMATION WAS NOT PROVIDED. NO PATIENT SAMPLE WAS PROVIDED FOR SIEMENS EVALUATION. NO PRODUCT PROBLEM WAS IDENTIFIED. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. CORRECTION MADE TO LOT NUMBER FROM GC0260 TO GE0260.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED A DISCORDANT ELEVATED TACROLIMUS (TAC) PATIENT RESULT OBTAINED ON A DIMENSION EXL 200 INSTRUMENT. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

A DISCORDANT, ELEVATED TACROLIMUS (TAC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INSTRUMENT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE DIMENSION INSTRUMENT AND AN EQUIVALENT RESULT WAS OBTAINED. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT AND A LOWER RESULT WAS OBTAINED AND REPORTED. THE LOWER RESULT WAS REGARDED AS CORRECT BY THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED TAC RESULT.