PHOSPHORUS
Received Feb 24, 2022 · Event occurred Feb 2, 2022
Report 3002809144-2022-00064 · MDR key 13592656
Device
Generic name
Phosphomolybdate (colorimetric), Inorganic Phosphorus
Manufacturer
Abbott GmbhModel number
7D71-23Catalog number
07D71-23
Lot number
01650UN21
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER STATED THAT DISCREPANT ARCHITECT PHOSPHORUS RESULTS WERE GENERATED FOR PATIENT SAMPLE ID (B)(6). AN INITIAL RESULT OF 0.94 MMOL/L WAS GENERATED (WITHIN NORMAL RANGE) AND THE CUSTOMER DECIDED TO RETEST THE SAMPLE WHICH RETESTED AT <0.21 MMOL/L (BELOW NORMAL RANGE) USING TWO DIFFERENT REAGENT LOTS. THE CUSTOMER USES SAMPLE COLLECTION TUBES WITH A SEPARATING GEL. IT IS SUSPECTED THAT THE SAMPLE PROBE POSSIBLY WENT INTO THE GEL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS UPDATED ON MARCH 14, 2022. MDR NUMBER 3016438761-2022-00144 HAS BEEN SUBMITTED FOR THE NEW SUSPECT MEDICAL DEVICE AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.
Description of Event or Problem
THE CUSTOMER STATED THAT DISCREPANT ARCHITECT PHOSPHORUS RESULTS WERE GENERATED FOR PATIENT SAMPLE ID (B)(6). AN INITIAL RESULT OF 0.94 MMOL/L WAS GENERATED (WITHIN NORMAL RANGE) AND THE CUSTOMER DECIDED TO RETEST THE SAMPLE WHICH RETESTED AT <0.21 MMOL/L (BELOW NORMAL RANGE) USING TWO DIFFERENT REAGENT LOTS. THE CUSTOMER USES SAMPLE COLLECTION TUBES WITH A SEPARATING GEL. IT IS SUSPECTED THAT THE SAMPLE PROBE POSSIBLY WENT INTO THE GEL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.