MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT C16000 SYSTEM; AUTOMATED CHEMISTRY ANALYZER

Catalog Number 03L77-01

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that critical low architect magnesium results were generated for five patient samples.None of the results were reported out of the laboratory.The samples were retested on a different architect analyzer and results were within the customer's normal range of 1.6 to 2.6 mg/dl.No adverse impact to patient management was reported.The following data was provided: patient 1: initial result of 0.7 retested at 1.8 mg/dl; patient 2: initial result of 0.7 retested at 1.8 mg/dl; patient 3: initial result of 0.8 retested at 2.0 mg/dl; patient 4: initial result of 0.7 retested at 2.0 mg/dl; patient 5: initial result of 0.8 retested at 2.3 mg/dl.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from the architect c16000 system, list 03l77-01, to clinical chemistry magnesium reagent, list 07d70-21.No device evaluation is required for the architect c16000 system, list 03l77-01.Device is no longer suspect.

• Brand Name: ARCHITECT C16000 SYSTEM
• 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: 5198490
• MDR Text Key: 30570367
• Report Number: 1628664-2015-00272
• Device Sequence Number: 0
• Product Code: JGJ
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

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: 03L77-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: No
• 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