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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH PHOSPHORUS; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
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ABBOTT GMBH PHOSPHORUS; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS Back to Search Results
Model Number 7D71-23
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2022
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
 
Event Description
The customer stated that discrepant architect phosphorus results were generated for patient sample id (b)(6).An initial result of 0.94 mmol/l was generated (within normal range) and the customer decided to retest the sample which retested at <0.21 mmol/l (below normal range) using two different reagent lots.The customer uses sample collection tubes with a separating gel.It is suspected that the sample probe possibly went into the gel.No adverse impact to patient management was reported.
 
Manufacturer Narrative
After further evaluation, the suspect medical device was updated on march 14, 2022.Mdr number 3016438761-2022-00144 has been submitted for the new suspect medical device and all further information will be documented under that mdr number.
 
Event Description
The customer stated that discrepant architect phosphorus results were generated for patient sample id (b)(6).An initial result of 0.94 mmol/l was generated (within normal range) and the customer decided to retest the sample which retested at <0.21 mmol/l (below normal range) using two different reagent lots.The customer uses sample collection tubes with a separating gel.It is suspected that the sample probe possibly went into the gel.No adverse impact to patient management was reported.
 
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Brand Name
PHOSPHORUS
Type of Device
PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM   65205
Manufacturer Contact
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key13592656
MDR Text Key289604137
Report Number3002809144-2022-00064
Device Sequence Number1
Product Code CEO
UDI-Device Identifier00380740161736
UDI-Public00380740161736
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K981759
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7D71-23
Device Catalogue Number07D71-23
Device Lot Number01650UN21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
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 Number1
Treatment
ARC C8 PROC MOD, 01G06-11, C804490.; ARC C8 PROC MOD, 01G06-11, C804490.
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