MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALP2 ALP IFCC GEN.2; NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES

Catalog Number	03333701190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results for 2 patient samples tested for alp2 alkaline phosphatase acc.To ifcc gen.2 (alp2) on a cobas 6000 c (501) module.Patient 1 was tested 3 times with results of less than 5 u/l with a data flag.These results are in question as the patient is known to have alp2 results of approximately 90 u/l.On (b)(6) 2023 patient 2 was tested 3 times with results of less than 5 u/l with a data flag.These results are in question as the patient is known to have alp2 results of approximately 70 u/l.The customer used 2 reagent lots for these patients: 730439 (expiration 29-feb-2024) and 747704 (expiration 31-may-2024).For both patients, all other results from other parameters were consistent with their previous results.The customer suspects an interference affecting the alp2 results for both patient samples.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).Calibration and qc were acceptable.No issues were identified during a review of the alarm trace.The investigation is ongoing.
Additional Manufacturer Narrative
Section b6 was updated.Section b7 was updated.Section d10 was updated.
Additional Manufacturer Narrative
Section d10 was updated.
Additional Manufacturer Narrative
The patient samples were submitted for investigation.The samples were tested for k+, iga, igg, igm, kappa, and lambda on a cobas c503 analyzer.For both samples: the k+ results were above the measuring range (> test) the protein results were normal since calibration and qc were acceptable, a general reagent issue can be excluded.Based on the reaction kinetics data provided, medication interference is not suspected.A gammopathic interference can be excluded since the reaction kinetics show no clouding and the kappa/lambda ratio was in the normal range.The high k+ results indicate excess k+ in the samples.The concentration of k+ in edta-plasma samples is extremely high.Based on this, the investigation determined the event was due to using an incorrect sample tube type.

• Brand Name: ALP2 ALP 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: 17671017
• Report Number: 1823260-2023-02854
• Device Sequence Number: 6324750
• Product Code: CJE
• UDI-Device Identifier: 04015630919505
• UDI-Public: 04015630919505
• 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,Followup,Followup
• Report Date (Section B): 03/29/2024

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 03333701190
• Device Lot Number: 730439, 747704
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 11/20/2023; 03/25/2024
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/19/2023; 12/11/2023; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1 - APROVEL; PATIENT 1 - FEBUXOSTAT; PATIENT 1 - HAMAMELIS VIRGINIANA; PATIENT 1 - ROSMARINUS OFFICINALIS; PATIENT 1 - UNSPECIFIED HYPERCHOLESTEROL MEDS; PATIENT 1 - UNSPECIFIED LIPID-LOWERING MEDICATION; PATIENT 1 - UNSPECIFIED PROSTATE MEDICATION; PATIENT 2 - METHOTREXATE; PATIENT 2 - CONSENTIX; PATIENT 2 - CONSENTIX - 1X/MONTH; PATIENT 2 - FORXIGA; PATIENT 2 - PROCORALAN; PATIENT 2 - SPIRONOLACTONE; PATIENT 2 ¿ METFORMIN
• Patient Sex: Male