1823260-2017-00824
Report
- Report Number
- 1823260-2017-00824
- Event Type
- Malfunction
- Date Received
- April 19, 2017
- Date of Event
- April 2, 2017
- Report Date
- June 12, 2017
- PMA / PMN Number
- K100853
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). (B)(6).
INITIALLY THE CUSTOMER REPORTED THEY HAD FURTHER ISSUES WITH THE CRP ASSAY AFTER THE SERVICE VISIT. HOWEVER, LATER THEY CONFIRM THAT THE ISSUE WAS RESOLVED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT NOT PROVIDED.
THE CUSTOMER EXPERIENCED ISSUES WITH THEIR QUALITY CONTROL RESULTS FOR CRPL3 C-REACTIVE PROTEIN GEN.3 AND REPEATED TESTING OF THE QUALITY MATERIAL SEVERAL TIMES BEFORE FINALLY STOPPING TESTING ON THIS ANALYZER. THE CUSTOMER REPEATED THE SAMPLES THAT HAD BEEN TESTED FOR CRP ON THIS ANALYZER ON ANOTHER ANALYZER IN THE LABORATORY. OF THE DATA PROVIDED FOR APPROXIMATELY 250 SAMPLES, THE RESULTS FOR 94 SAMPLES WERE DISCREPANT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE COLUMN LABELED "PRELIMINARY RESULT" IS THE ERRONEOUS INITIAL RESULT. THE COLUMN LABELED "RESULT" IS THE REPEAT RESULT FROM THE OTHER ANALYZER. THE UNIT OF MEASURE WAS NOT PROVIDED. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT IT WAS UNKNOWN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 202453. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE GEAR PUMP PRESSURE, ADJUSTED WASH LEVELS, AND REMOVED AND CLEANED THE ULTRASONIC MIXERS. QC WAS PERFORMED AND WAS ACCEPTABLE.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |