MAUDE Adverse Event Report: ABBOTT GMBH PHOSPHORUS; PHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS

Model Number	7D71-23
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: PHOSPHORUS
• Common Device Name: 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 Key: 13592656
• Report Number: 3002809144-2022-00064
• Device Sequence Number: 19798534
• Product Code: CEO
• UDI-Device Identifier: 00380740161736
• UDI-Public: 00380740161736
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K981759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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 Model Number: 7D71-23
• Device Catalogue Number: 07D71-23
• Device Lot Number: 01650UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C8 PROC MOD, 01G06-11, C804490.; ARC C8 PROC MOD, 01G06-11, C804490.
• Patient Sex: Unknown