LDHI2 LACTATE DEHYDROGENASE
Received Jan 24, 2018 · Event occurred Jan 9, 2018
Report 1823260-2018-00228 · MDR key 7216397
Device
Generic name
Lactate Dehydrogenase Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05169330190
Lot number
280352
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE LDHI2 LACTATE DEHYDROGENASE RESULTS FOR MULTIPLE PATIENT SAMPLES AFTER MONTHLY MAINTENANCE WAS PERFORMED ON COBAS 8000 C 702 MODULE SERIAL NUMBER (B)(4). MOST OF THE RESULTS WERE ACCOMPANIED BY DATA FLAGS. OF THE DATA PROVIDED FOR 10 PATIENT SAMPLES, ONLY THE RESULTS FOR THREE PATIENT SAMPLES WERE DISCREPANT. PATIENT 1: INITIAL RESULT WAS 440 U/L AND THE REPEAT RESULTS FROM OTHER COBAS 8000 C 702 MODULES ON (B)(6) 2018 WERE 215 U/L AND 213 U/L. PATIENT 2: INITIAL RESULT WAS 376 U/L AND THE REPEAT RESULTS FROM OTHER COBAS 8000 C 702 MODULES WERE 188 U/L AND 188 U/L. PATIENT 3: INITIAL RESULT WAS 398 U/L AND THE REPEAT RESULTS FROM OTHER COBAS 8000 C 702 MODULES WERE 240 U/L AND 240 U/L. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ADVERSE EVENT. AS NO OTHER ENZYMATIC ASSAYS HAD ISSUES, THE CUSTOMER SUSPECTED THERE WAS AN ISSUE WITH THE REAGENT PACK. THE CUSTOMER REPLACED THE REAGENT PACK WHICH RESOLVED THE ISSUE.
Additional Manufacturer Narrative
FOLLOW UP WITH THE CUSTOMER CONFIRMED THE ISSUE WAS RESOLVED BY REPLACEMENT OF THE REAGENT PACK. A QUERY WAS PERFORMED AND FOUND NO PAST ESCALATED COMPLAINTS OF THIS NATURE ON ANY LIKE INSTRUMENTS FOR THE LAST 12 MONTHS AT THIS SITE.