MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2; NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Catalog Number	08056757190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).Calibration and quality control data were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with alkaline phosphatase acc.To ifcc gen.2 on a cobas c 503 analytical unit.The first sample initially resulted in an alp value of 1157 u/l.The sample was repeated five times, resulting in values of 486 u/l with a data flag, 819 u/l, 410 u/l, 409 u/l, and 442 u/l.The sample was diluted 1:5 and repeated, resulting in an alp value of 234 u/l.The repeat value of 234 u/l was believed to be correct.The second sample initially resulted in an alp value of 345 u/l.The sample was repeated three times, resulting in values of 522 u/l, 391 u/l, and 367 u/l.The sample was diluted 1:5 and repeated, resulting in an alp value of 357 u/l.The repeat value of 357 u/l was believed to be correct.The third sample initially resulted in an alp value of 729 u/l.The sample was repeated twice, resulting in values of 445 u/l and 439 u/l.The sample was diluted 1:5 and repeated, resulting in an alp value of 437 u/l.The repeat value of 437 u/l was believed to be correct.The fourth sample initially resulted in an alp value of 206 u/l on (b)(6) 2024.The sample was repeated twice, resulting in values of 113 u/l and 91 u/l.The sample was re-centrifuged and placed in a sample cup then repeated, resulting in a value of 83 u/l.
Additional Manufacturer Narrative
All affected patients have myeloma with high white blood cell counts.Samples with hyper-leukocytosis may show higher alp activity due to the presence of leukocytes, debris, and platelets.A reagent issue is unlikely because calibration and qc data are acceptable.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• Brand Name: ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2
• Common Device Name: NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20171306
• Report Number: 1823260-2024-02599
• Device Sequence Number: 20593139
• Product Code: CJE
• UDI-Device Identifier: 07613336120972
• UDI-Public: 07613336120972
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K033185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08056757190
• Device Lot Number: 807290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown