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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM
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ABBOTT GMBH MAGNESIUM Back to Search Results
Model Number 03P6832
Medical Device Problem Code High Test Results (2457)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency was identified.
 
Event or Problem Description
The customer observed falsely elevated magnesium results: initial 11.66 mg/dl; repeat 1.8 mg/dl on the architect c16000 system.The customer's reference range is 1.6 to 2.6 mg/dl.There was no impact to patient management reported.
 
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Brand Name
MAGNESIUM
Common Device Name
MAGNESIUM
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key10138775
Report Number3002809144-2020-00461
Device Sequence Number2152938
Product Code JGJ
UDI-Device Identifier00380740161637
UDI-Public00380740161637
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/10/2020
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
Operator of Device Health Professional
Device Expiration Date10/24/2020
Device Model Number03P6832
Device Catalogue Number03P68-32
Device Lot Number77040UN19
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/08/2020
Initial Report FDA Received Date06/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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