MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 03P68-21

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2014

Event Type  malfunction  

Event Description

The customer stated that discrepant magnesium results were generated for patient samples tested on the architect c4000 analyzer.Patient #4 initial result of 4.6 mg/dl retested at <0.7 mg/dl three times.Patient #5 initial result of >6.4 mg/dl retested at 2.3 and 1.9 mg/dl.No adverse impact to patient management was reported.

Manufacturer Narrative

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

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from clinical chemistry magnesium, list 03p68, manufacturing site abbott manufacturing inc, (b)(4), in this report to architect c4000 analyzer, list 02p24, manufacturing site abbott manufacturing inc, (b)(4).The suspect medical device was changed on (b)(6) 2014.Mdr number 1628664-2014-00235 has been submitted and all further information will be documented under that mdr number.

• Brand Name: CLINICAL CHEMISTRY MAGNESIUM
• Type of Device: MAGNESIUM
• 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: 4166936
• MDR Text Key: 4787850
• Report Number: 1628664-2014-00222
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981791
• 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: 09/17/2014

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 Catalogue Number: 03P68-21
• Device Lot Number: 26126UN14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 10/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER; LIST 02P24-40, SERIAL (B)(4)