InjuryJKP
ACL ELITE
Received Feb 11, 2015
Report MW5040773 · MDR key 4528273
Device
Generic name
Coagulation Instrument
Manufacturer
Instrumentation Laboratory CoProduct problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
32 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CHANGES IN LABORATORY VALUES. EQUIPMENT TAKEN OUT OF SERVICE AND MANUFACTURER CONTACTED FOR THE TROUBLESHOOTING. SERVICE COMPLETED ON (B)(6) 2015. THE SAMPLE BLOCK ASSEMBLY WAS REPLACED AND EQUIPMENT RETURNED TO SERVICE AT THAT TIME. NO APPARENT LONG-TERM ADVERSE EFFECT FOR THE PATIENTS.