ANALYTICAL P MODULE
Received Feb 23, 2010 · Event occurred Jan 12, 2010
Report 1823260-2010-01169 · MDR key 1611625
Device
Generic name
Clincal Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03261603001
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE USER RECEIVED A DISCREPANT CALCIUM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.68 MG/DL AND WAS REPORTED. ON (B)(6) 2010, A REQUEST TO REPEAT THE CALCIUM ASSAY ON THE SAME SAMPLE WAS SENT AND RESULTS OF 4.38 AND 4.47 MG/DL WERE GENERATED ON ANOTHER P MODULE AT THE SITE. THE SAMPLE WAS THEN REPEATED ON THE ORIGINAL ANALYZER AND RESULTS OF 4.23 AND 4.38 MG/DL WERE GENERATED. THE PATIENT RECEIVED TREATMENT FOR HYPOCALCAEMIA. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT WAS 617260. IT WAS DETERMINED THE SST SERUM SAMPLE TUBE WAS CENTRIFUGED FOR 7 MINUTES AT 3000 RPMS AT 20 DEGREES C WHICH WAS NOT IN ACCORDANCE WITH THE TUBE MANUFACTURER'S SPECIFICATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION CONCERNING THE PATIENT WAS PROVIDED: "AT ADMISSION TO THE ER, THE PATIENT WAS ON METFORMIN 1000 MG BID, ATORVASTATIN 10 MG DAILY, ASA 325 MG DAILY, IRBESARTAN 150 MG DAILY, TYLENOL#3 WHEN NEEDED, SYMBICORT 200/6 INHALER AS NEEDED." THE PATIENT RECEIVED CHEMOTHERAPY FOR HIS MYELOMA, BUT NO SPECIFIC INFORMATION WAS PROVIDED.
Description of Event or Problem
THE USER RECEIVED A DISCREPANT CALCIUM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.68 MG/DL AND WAS REPORTED. ON (B) (6) 2010, A REQUEST TO REPEAT THE CALCIUM ASSAY ON THE SAME SAMPLE WAS SENT AND RESULTS OF 4.38 AND 4.47 MG/DL WERE GENERATED ON ANOTHER P MODULE AT THE SITE. THE SAMPLE WAS THEN REPEATED ON THE ORIGINAL ANALYZER AND RESULTS OF 4.23 AND 4.38 MG/DL WERE GENERATED. THE PATIENT RECEIVED TREATMENT FOR HYPOCALCAEMIA. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT WAS 617260. IT WAS DETERMINED THE SST SERUM SAMPLE TUBE WAS CENTRIFUGED FOR 7 MINUTES AT 3000 RPMS AT 20 DEGREES C WHICH WAS NOT IN ACCORDANCE WITH THE TUBE MANUFACTURER'S SPECIFICATION.
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem
THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE WAS NOT IDENTIFED. NO PROBLEMS WERE FOUND WITH CALIBRATION, QUALITY CONTROL, AND PRECISION RECOVERY. POSSIBLE CAUSES FOR THE EVENT INCLUDE SAMPLE OR REAGENT NEEDLE PIPETTING ERROR, PRE- ANALYTICAL SAMPLE HANDLING, AND SAMPLE CONTAMINATION.