MalfunctionMLM

DIMENSION®

Received Feb 10, 2023 · Event occurred Jan 13, 2023

Report 2517506-2023-00057 · MDR key 16351495

Device

Generic name

Dimension® Tacrolimus Flex® Reagent Cartridge

Manufacturer

Siemens Healthcare Diagnostics Inc.

Model number

10700795

Catalog number

DF207 SMN 10700795

Lot number

GA3192

Product problems

Low Test Results
Low Test Results

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (13-MAR-2024): SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS INVESTIGATION DID NOT IDENTIFY A MEDICAL DEVICE MALFUNCTION. BASED ON THE INVESTIGATION, SHIPPING AND HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THIS EVENT. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2517506-2023-00057 WAS FILED ON (B)(6) 2023. INITIAL MDRS 2517506-2023-00055, 2517506-2023-00056, 2517506-2023-00058, 2517506-2023-00059, 2517506-2023-00060, 2517506-2023-00061, 2517506-2023-00062, 2517506-2023-00063 AND 2517506-2023-00064 WERE ALSO FILED FOR THE SAME EVENT ON (B)(6)2023. SUPPLEMENTAL MDRS 2517506-2023-00055 SUPPLEMENT 1, 2517506-2023-00056 SUPPLEMENT 1, 2517506-2023-00058 SUPPLEMENT 1, 2517506-2023-00059 SUPPLEMENT 1, 2517506-2023-00060 SUPPLEMENT 1, 2517506-2023-00061 SUPPLEMENT 1, 2517506-2023-00062 SUPPLEMENT 1, 2517506-2023-00063 SUPPLEMENT 1, AND 2517506-2023-00064 SUPPLEMENT 1 ARE FILED FOR THE SAME EVENT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS OBTAINED ON TWO (2) DIMENSION EXL 200 SYSTEMS. MDRS 2517506-2023-00055, 2517506-2023-00056, 2517506-2023-00058, 2517506-2023-00059, 2517506-2023-00060, 2517506-2023-00061, 2517506-2023-00062, 2517506-2023-00063 AND 2517506-2023-00064 ARE FILED FOR THE SAME EVENT. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

DISCORDANT FALSELY DEPRESSED TACROLIMUS (TAC) PATIENT SAMPLE RESULTS WERE OBTAINED ON TWO (2) DIMENSION EXL 200 SYSTEMS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED AT A LATER DATE(S) ON AN ALTERNATE NON-SIEMENS SYSTEM. HIGHER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TACROLIMUS (TAC) RESULTS.