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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C LACTATE DEHYDROGENASE REAGENT KIT; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
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ABBOTT GMBH ALINITY C LACTATE DEHYDROGENASE REAGENT KIT; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE Back to Search Results
Model Number 07P7420
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2021
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer due to privacy issues.
 
Event Description
The customer reported falsely elevated alinity c lactate dehydrogenase (ldh) results on one patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial ldh = 247u/l (reference range 125-220u/l)/ retest one hour later = 153u/l and 140u/l.There was no reported impact to patient management.
 
Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity c lactate dehydrogenase reagent kit, list number 07p74-20, and manufacturing site abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205 in section d of this report to alinity c processing module, list number 03r67-01, and manufacturing site of abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205.Mdr number 3002809144-2021-00114-00 has been submitted and all further information will be documented under that mdr number.After further evaluation, the suspect medical device was changed from alinity c lactate dehydrogenase reagent kit, list number 07p74-20, and manufacturing site abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205 in section d of this report to alinity c processing module, list number 03r67-01, and manufacturing site of abbott gmbh, max-planck-ring 2, wiesbaden, germany, 65205.Mdr number 3002809144-2021-00114-00 has been submitted and all further information will be documented under that mdr number.
 
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Brand Name
ALINITY C LACTATE DEHYDROGENASE REAGENT KIT
Type of Device
NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key11250446
MDR Text Key229391125
Report Number3002809144-2021-00067
Device Sequence Number1
Product Code CFJ
UDI-Device Identifier00380740130244
UDI-Public00380740130244
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/26/2021
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 Model Number07P7420
Device Catalogue Number07P74-20
Device Lot Number83393UN20
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/11/2021
Initial Date FDA Received01/29/2021
Supplement Dates Manufacturer Received02/12/2021
Supplement Dates FDA Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY C PROCESSING MODU, 03R67-01, AC02351; ALNTY C PROCESSING MODU, 03R67-01, AC02351; ALNTY C PROCESSING MODU, 03R67-01, (B)(4)
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