MAUDE Adverse Event Report: ABBOTT GMBH CALCIUM; AZO DYE, CALCIUM

Model Number 3L79-22

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/10/2022

Event Type  malfunction  

Event Description

The customer observed discrepant calcium results generated on an architect c4000 analyzer for two patients when compared to results generated on another analyzer.The customer provided reference range is 6.3-11.9 mg/dl.Sid: (b)(4) initial result = 6.7 mg/dl, repeat =6.6 mg/dl, repeat on another analyzer = 6.0 mg/dl.Sid (b)(4) initial result = 3.0 mg/dl, repeat result = 3.1 mg/dl, repeat result on another analyzer = 7.5 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

Sid: 1000812: (b)(6).Sid 10800712a: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history review.Return testing was not complete as returns were not available.A search for similar tickets did not reveal an increase in complaint activity.The trend review found no trends related to this issue.Device history record review did not identify any non-conformances or deviations related to the current complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the calcium reagent lot 10782un21 was identified.

• Brand Name: CALCIUM
• Type of Device: AZO DYE, CALCIUM
• 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: 14250500
• MDR Text Key: 290520638
• Report Number: 3002809144-2022-00145
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2022
• Device Model Number: 3L79-22
• Device Catalogue Number: 03L79-22
• Device Lot Number: 10782UN21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, C400707.; ARC C4000 INTGR, 02P24-40, C400707.