MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ARCHITECT CLINICAL CHEMISTRY MAGNESIUM

Catalog Number 07D70-21

Device Problem Low Test Results (2458)

Patient Problems Misdiagnosis (2159); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

The customer reports that two different blood samples from the same patient generated clinical chemistry magnesium assay results of <0.2 mg/dl on one architect c4000 analyzer.The customer uses a normal reference range of 1.8 to 2.5 mg/dl with critical limits set at less than 1.0 mg/dl and greater than 6.2 mg/dl.The results were reported from the lab and the patient was diagnosed as hypo-magnesium.The patient was transferred to another facility where an unknown amount of magnesium was administered.A subsequent blood draw resulted in a magnesium value of 2.6 mg/dl.The customer retested the two original samples drawn at their facility on a different architect c4000 analyzer at their lab and generated results of 2.0 mg/dl (sample (b)(6)) and 1.9 mg/dl (sample (b)(6)).Controls have been within specifications on all runs.The customer uses green top tubes (lithium heparin plasma) with gel separators and did not note anything unusual regarding the samples' appearance.There are no reports of any adverse impact to the patient as a result of this event.

Manufacturer Narrative

There were no returns made available from the customer site for this evaluation.Information from the customer site found that the original samples were not centrifuged per tube manufacturer's guidelines as directed by the architect clinical chemistry magnesium assay package insert.The customer had centrifuged the tubes at 2900 rpm for six minutes.The tube manufacturer's instructions state to centrifuge at a maximum of 1300 rpm for 10 minutes (swing bucket) or 15 minutes (fixed angle).A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.The clinical chemistry magnesium assay package insert and the architect system operations manual both contain information to address the current customer issue.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.The issue was sample specific and addressed through standard troubleshooting procedures.(b)(4).

• Brand Name: ARCHITECT 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: 4379761
• MDR Text Key: 5238548
• Report Number: 1628664-2015-00003
• 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: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Catalogue Number: 07D70-21
• Device Lot Number: 63810UN14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C4000 ANALYZER LN: 02P24-40; SN: (B)(4)
• Patient Outcome(s): Other
• Patient Age: 68 YR