MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number 03P68-22

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

Full patient sid is (b)(6).No further patient information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer identified discrepant magnesium results generated with the architect c4000 processing module.The following was provided: sid (b)(6) initial result 1.27 mmol/l, repeated 0.46 and 0.45 mmol/l.On (b)(6) 2021 sid: (b)(6) initial result 1.01 mmol/l, repeated 0.52, 0.51 and 0.51 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

D4 expiration date and h4 manufacture date were inadvertently omitted.

Event Description

Sid (b)(6), initial result 1.27 mmol/l, repeated 0.46 and 0.45 mmol/l.(b)(6) 2021, sid: (b)(6), initial result 1.01 mmol/l, repeated 0.52, 0.51 and 0.51 mmol/l.An additional sample was identified by the customer on (b)(6) 2021: (b)(6) 2021, sid (b)(6), initial result 0.49 mmol/l, repeated 1.28, 0.49, and 0.49 mmol/l.No impact to patient management was reported.

Event Description

Sid (b)(6) initial result 1.27 mmol/l, repeated 0.46 and 0.45 mmol/l (b)(6) 2021; sid: (b)(6) initial result 1.01 mmol/l, repeated 0.52, 0.51 and 0.51 mmol/l.An additional sample was identified by the customer on (b)(6) 2021: (b)(6) 2021 sid (b)(6) initial result 0.49 mmol/l, repeated 1.28, 0.49, and 0.49 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

Section a1 and b5 was updated as an additional patient sid was provided on 14 sep 2021.The customer noted the results for this additional sid were generated on 14 sep 2021.A review of tickets was performed for reagent lot number 59201un20.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the magnesium reagent, lot number 59201un20 was identified.B3 - date of event was update to correspond with the date incorrect results were first generated.Section d - catalog number, lot number, manufacturing location, manufacturing contact information and udi were corrected.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden TX 65205 ; GM 65205
• MDR Report Key: 12348477
• MDR Text Key: 267477633
• Report Number: 3016438761-2021-00304
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• PMA/PMN Number: K981791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: 03P68-22
• Device Lot Number: 59201UN20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4 PROC MOD, 02P24-01, C460943; ARC C4 PROC MOD, 02P24-01, C460943; ARC C4 PROC MOD, 02P24-01, C460943; ARC C4 PROC MOD, 02P24-01, (B)(4)