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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES LACTATE DEHYDROGENASE
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ABBOTT LABORATORIES LACTATE DEHYDROGENASE Back to Search Results
Catalog Number 02P56-21
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2019
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.
 
Event Description
The customer observed a falsely elevated lactate dehygrogenase (ldh) result while using the clinical chemistry ldh assay.The customer indicated the patient was admitted after the initial result was generated.The following results were provided: initial 1154, retest results: 214, 209 and 215 u/l no impact to patient management was reported.
 
Manufacturer Narrative
The incorrect manufacturing location was documented in manufacturer name, city and state.Please refer to manufacture report number 1628664-2019-00286 for all further information.Device evaluated by mfr: an evaluation is in-process.
 
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Brand Name
LACTATE DEHYDROGENASE
Type of Device
LACTATE DEHYDROGENASE
Manufacturer (Section D)
ABBOTT LABORATORIES
100 abbott park road
abbott park IL 60064 3500
MDR Report Key8411818
MDR Text Key138549608
Report Number1415939-2019-00014
Device Sequence Number1
Product Code CFJ
UDI-Device Identifier00380740004033
UDI-Public00380740004033
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/03/2019
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 Number02P56-21
Device Lot Number73199UN18
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/19/2019
Initial Date FDA Received03/12/2019
Supplement Dates Manufacturer Received04/03/2019
Supplement Dates FDA Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT C8000 PROCESS MODULE; ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(4); LN 01G06-11, SN (B)(4); ARCHITECT C8000 PROCESS MODULE; LN 01G06-11, SN (B)(4)
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