MINIVIDAS INSTRUMENT
Received Feb 16, 2015 · Event occurred Jan 13, 2015
Report 3002769706-2015-00001 · MDR key 4518587
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Biomerieux Italia-industrial Div. 8Catalog number
99737
Product problems
- False Positive Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2015, A CUSTOMER CONTACTED THE US BIOMERIEUX SUBSIDIARY TO REPORT A QUALITY CONTROL CHECK FAILURE THAT OCCURRED DURING THE USE OF A MINIVIDAS INSTRUMENT. RETROSPECTIVE ANALYSIS OF THE CELL IN QUESTION REVEALED A SINGLE FALSE POSITIVE RESULT. THE PATIENT SAMPLE WAS TESTED ON (B)(6) 2015 AND INDICATED POSITIVE FOR TROPONIN (INDICATION OF MYOCARDIAL INFARCTION). BASED ON THE RESULT OF THE TEST, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER TESTING AND MONITORING. A REPEAT BLOOD DRAW AND TEST WAS PERFORMED ON (B)(6) 2015; INDICATING NEGATIVE FOR TROPONIN. AN ADDITIONAL BLOOD DRAW AND TEST WAS CONDUCTED ON (B)(6)2015; INDICATING NEGATIVE FOR TROPONIN. AS A RESULT OF THE TWO NEGATIVE RESULTS, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CUSTOMER HAS NOT PROVIDED ANY DETAILS REGARDING TREATMENT WHILE THE PATIENT WAS IN THE HOSPITAL. THE CUSTOMER HAS CONFIRMED THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE FALSE POSITIVE INDICATION OR ADMISSION TO THE HOSPITAL. AS A RESULT OF THE REPORTED COMPLAINT, A FIELD SERVICE ENGINEER WAS SENT TO THE SITE AND DETERMINED THAT THE QUALITY CONTROL CHECK FAILURE WAS CAUSED BY AN OBSTRUCTION OF THE PUMP FOR THE CELL IN QUESTION. THE ENGINEER REMOVED THE OBSTRUCTION AND INSTRUMENT IS NOW PERFORMING AS INTENDED.