MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE INDIRECT K+ FOR GEN.2; ELECTRODE, ION SPECIFIC, POTASSIUM

Catalog Number	10825441001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer received questionable high ise indirect gen.2 potassium results for patient sample from the cobas 6000 c501 module serial number (b)(4).The customer suspected an interference with the lithium heparin samples.The initial result from a lithium heparin sample was 8.08 mmol/l and was reported outside of the laboratory to the doctor.The patient was moved to intensive care.A new (citrated plasma) sample was drawn and the potassium result was 4.80 mmol/l.A third (lithium heparin) sample was drawn and the result was >10.0 mmol/l with a data flag.This sample was then tested on a bga (abl 90 flex) and the result was 9.6 mmol/l.A fourth (citrated plasma) sample was drawn and the result was 3.7 mmol/l on the cobas c501 analyzer and the result was 3.7 mmol/l on the abl 90 flex analyzer.On (b)(6) 2018, a fifth (lithium heparin) sample was drawn and the result was 4.15 mmol/l.There was no allegation of an adverse event.
Additional Manufacturer Narrative
The investigation determined the elevated potassium results from the lithium heparin samples were caused by "reverse pseudohyperkalemia".Lymphoma cells in the plasma samples lyse during centrifugation and increase the potassium concentration.There was no malfunction of the device or product problem found.

• Brand Name: ISE INDIRECT K+ FOR GEN.2
• Common Device Name: ELECTRODE, ION SPECIFIC, POTASSIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8074136
• Report Number: 1823260-2018-04327
• Device Sequence Number: 16567284
• Product Code: CEM
• UDI-Device Identifier: 08430215011539
• UDI-Public: 8430215011539
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 07/15/2019
• Device Catalogue Number: 10825441001
• Device Lot Number: S36_2018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/07/2018
• 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: ADENURIC; L-THYROXIN; PREDNISONE; TAMOXIFEN; ZOPLICON
• Patient Age: 20 YR