MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C4000 ANALYZER; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 02P24-40

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that elevated architect magnesium results were generated on 2 patients.Patient 1 an initial result of 7.0 mg/dl was generated and reported.The result was questioned and repeated with a result of 2.1 mg/dl.Patient 2: an initial result of 7.3 mg/dl was generated and reported.The sample was questioned and repeated with a result of 1.9 mg/dl.The customer was using a normal range of 1.8 - 2.6 mg/dl.There was no report of impact to patient management.

Manufacturer Narrative

The customer indicated that the architect c4000 analyzer generated falsely elevated magnesium results on two patients.An abbott field service representative (fsr) was dispatched to the account.The fsr noted that the mixer wash cup was clogged/obstructed.The fsr cleaned the mixer wash cup to resolve the issue.There were no additional occurrences of discrepant results after the mixer wash cup was cleaned.Customer complaint data was reviewed and no adverse trends were identified which were associated with the mixer wash cup or erratic/discrepant results.The architect system operations manual was reviewed and was found to adequately address the issue.Information is provided regarding troubleshooting and maintenance related to erratic/discrepant results.The investigation did not identify a malfunction / deficiency.

• Brand Name: ARCHITECT C4000 ANALYZER
• Type of Device: AUTOMATED CHEMISTRY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5205919
• MDR Text Key: 30698186
• Report Number: 1628664-2015-00274
• Device Sequence Number: 0
• Product Code: JGJ
• Reporter Country Code: US
• PMA/PMN Number: K980367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02P24-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1