MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS C16000 CHEMISTRY ANALYZER

Model Number C16000

Device Problems Crack (1135); False Positive Result (1227); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

Abbott architect c analyzer reported falsely elevated magnesium level on a patient, 6.2 mg/dl.A critical value was called to the clinician at night and verified in the patient's medical record for the 6.2 mg/dl magnesium.As the patient was taking magnesium supplements, it was recommended that the patient go to the nearest emergency room.Patient went to a local medical center on (b)(6) and had chemistry and hematology tests repeated.Magnesium was 1.7 mg/dl.Manufacturer investigated the analyzer, found a cracked cuvette that was leaking water from the incubation bath into the cuvette during the test.Analyzer failed to detect the cracked cuvette and allowed testing to be conducted in a bad reaction cuvette.This was the second incident in previous 3 months where a false result was not detected by the analyzer, test was conducted in a bad cuvette, and incorrect results reported on a patient.Other manufacturers of automated chemistry analyzers on the market (roche, beckman, siemens) perform a cuvette check between each test and will cancel use of any cuvettes that demonstrate significant changes in absorbance before and after a test.This presents use of dirty, scratched or cracked cuvettes and flags the operator for maintenance error to change the cuvette.Abbott architect analyzers are failing to detect bad cuvettes and allowing testing to be conducted with compromised results and no error code or flag to the operator to indicate a test problem.This patient fortunately, did not suffer significant patient care impact, although the patient did have additional lab testing performed as a result of the critical magnesium value.

• Brand Name: C16000 CHEMISTRY ANALYZER
• Type of Device: C16000 CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS; abbott park IL
• MDR Report Key: 3636724
• MDR Text Key: 3984293
• Report Number: MW5034551
• Device Sequence Number: 1
• Product Code: JGJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2014

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
• Device Operator: Health Professional
• Device Model Number: C16000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other