STAT PROFILE PRIME PLUS ANALYZER SYSTEM
Received Sep 4, 2019 · Event occurred Aug 4, 2019
Report 1219029-2019-00045 · MDR key 8959569
Device
Product problems
- Incorrect Measurement
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect Measurement
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE INVESTIGATION: A NOVA BIOMEDICAL TECHNICIAN PERFORMED A FIELD SERVICE SUPPORT FOLLOW-UP VISIT TO THE USER FACILITY, AND DURING INSPECTION OF THE ANALYZER, THE TECHNICIAN FOUND THAT THE SAMPLE PROBE S-LINE WAS KINKED. THE TECHNICIAN REPLACED THE SAMPLER ASSEMBLY TO CORRECT THE ISSUE. UPON EXAMINATION OF THE RETURNED S-LINE TO THE MANUFACTURER, A BREAK WAS OBSERVED IN THE KINKED SECTION OF THE S-LINE. THIS BREAK WOULD PREVENT FLOW, CAUSE ERRORS, AND THE ANALYZER WOULD NOT CALIBRATE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE BREAK WAS PRESENT DURING THE TIME OF THE DISCREPANT CALCIUM RESULTS. DEVICE HISTORY REVIEWS (DHRS) WERE PERFORMED ON THE ANALYZER, S-LINE, AND REFERENCE CARTRIDGE BATCHES. NO ABNORMALITIES WERE OBSERVED, AND THE DHRS INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THE COMPLAINT COULD NOT BE CONFIRMED.
Additional Manufacturer Narrative
INVESTIGATION IN PROCESS, NO PATIENT IMPACT WAS REPORTED. CUSTOMER WAS UNABLE TO PROVIDE ANY PATIENT ICA VALUES BUT STATED THAT QUALITY CONTROL WAS IN RANGE BEFORE AND AFTER INCIDENT OCCURED.
Description of Event or Problem
CUSTOMER REPORTED DISCREPANT IONIZED CALCIUM RESULT USING NOVA STAT PROFILE PRIME PLUS ANALYZER, SN (B)(4), WHEN COMPARED TO OTHER PRIME PLUS ANALYZER. NO ADVERSE EVENT WAS REPORTED.