CLINICAL CHEMISTRY PHOSPHORUS
Received May 3, 2017 · Event occurred Aug 7, 2016
Report 1628664-2017-00175 · MDR key 6541452
Device
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT DATA, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE CLINICAL CHEMISTRY PHOSPHORUS ASSAY, LIST NUMBER 07D71, LOT 91772UN16, WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY DECREASED CLINICAL CHEMISTRY PHOSPHORUS RESULTS FOR FIVE PATIENTS. THE CUSTOMER INDICATED THEY WERE GENERATING RESULTS OF <0.7 MG/DL FOR EACH PATIENT, THE RETEST WAS WITHIN RANGE. INITIAL AND RETEST RESULTS FOR FOUR OF THE FIVE PATIENTS WAS PROVIDED AS FOLLOWS: ON (B)(6) 2016: INITIAL <0.7 MG/DL, RETESTED ON (B)(6) 2016 ON A SECOND ANALYZER: 2.0 MG/DL SID (B)(6) INITIAL <0.7, RETEST 1.8 MG/DL; SID (B)(6) INITIAL <0.7, RETEST 2.0 MG/DL; SID (B)(6) INITIAL <0.7, RETEST 2.0 MG/DL. (CUSTOMER NORMAL PATIENT RANGE 2.3 - 4.7 MG/DL). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.