FDA Adverse Event Injury Summary report: N

UNICEL DXC600I SYNCHRON CLINICAL SYSTEM

MDR report key: 1732129 · Received June 18, 2010

Report

Report Number
1732129
Event Type
Injury
Date Received
June 18, 2010
Date of Event
June 6, 2010
Report Date
June 17, 2010
Manufacturer
BECKMAN COULTER
Product Code
MZV
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A (B)(6) YEAR OLD PATIENT ARRIVED PER AMBULANCE WITH CONFUSION, WEAKNESS, CHILLS, OOZING FROM LEGS AND SWELLING WITH FEVER AND HYPOTENSION. ADMITTED WITH ACUTE RENAL FAILURE, SEPSIS, COUMADIN TOXICITY, ACUTE DEHYDRATION, HYPERKALEMIA. REQUIRED EMERGENT DIALYSIS. INITIAL POTASSIUM RESULTS REPORTED AS CRITICAL HIGH VALUE OF 8.1 AT 0033 ON (B)(6) 2010 AFTER RECHECKED. (THE REFERENCE RANGE FOR THIS FACILITY IS 3.4-4.8 MG/DL). AT 0230 ON (B)(6) 2010, THE PHYSICIAN ORDERED THAT THE PATIENT BE REDRAWN FOR A BASIC METABOLIC PROFILE (BMP) AS A STAT. AT 0415, THE RESULTS FOR THAT TESTING WERE REPORTED. AT THIS TIME, THE POTASSIUM WAS REPORTED AS A 6.7 MG/DL. ON THE MORNING OF (B)(6) 2010, THE CLINICAL SUPERVISING PATHOLOGIST FOR THE CHEMISTRY DEPARTMENT, FOUND THIS VARIATION OF RESULTS IN THIS TIMEFRAME TO BE QUESTIONABLE FOR THIS PATIENT. HE ASKED THAT THE 2307 SPECIMEN FROM (B)(6) 2010 BE RERUN ON BOTH INSTRUMENTS. RESULTS OF 6.9MG/DL AND 7.0MG/DL WERE OBTAINED. A CORRECTED REPORT, CHANGING THE 8.1 POTASSIUM RESULT TO A 6.9 RESULT, WAS ISSUED AT 1152 ON (B)(6) 2010. THE PATIENT'S PHYSICIAN, WAS NOTIFIED AT 1130 ON (B)(6) 2010 COMMUNICATING THAT A CORRECTED REPORT WOULD BE ISSUED TO AMEND THE 8.1 POTASSIUM RESULT VERIFIED AT 0033 ON (B)(6) 2010 TO 6.9MG/DL. THE PATIENT'S PHYSICIAN SAID THAT THE EKG SHOWED NO CHANGES OF HYPERKALEMIA AND SO CORRELATED MUCH BETTER WITH THE 6.9 RESULT RATHER THAN THE 8.1 RESULT. THE PATIENT'S POTASSIUM OF 8.1 WAS TREATED WITH 30 GM OF KAYEXALATE ON (B)(6) 2010 AS A STAT ORDER AT 0035 AND ALSO 3GM/30ML IVPB OF CALCIUM GLUCONATE AT 0048 ON (B)(6) 2010. THE PATIENT ALSO REQUIRED EMERGENT DIALYSIS FOR ELEVATED BUN AND EXCESSIVE FLUID.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNICEL DXC600I SYNCHRON CLINICAL SYSTEM BECKMAN COULTER ASSESS 2 DXC600I MZV BECKMAN COULTER 4767 NA

Patients

Seq Age Sex Outcome Treatment
1 86 YR Other| R