MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP SAL ARKRAY HA-8180V; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 06Q62-01

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

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed discrepant hba1c results for one sid (b)(6) on abbott glp sal arkray module.The customer received two hba1c results for one patient.The results provided were: sid (b)(6) using car 41006 initial=68 mmol/mol /repeated=50 mmol/mol; repeated on standalone module= 50 mmol/mol.The sid (b)(6) moved through glp to arkray access point in car (b)(6), the tac (tube assessment center) input module of the glp track read the barcode and it will link it to the car rfid (radio frequency identification) (b)(6).The glp sal (sample access line) read car rfid and got stuck there at access point due to sticking label.The customer push manually that car (b)(6).The arkray aspirated blood from next specimen in line and got results 68 mmol/mol for sid (b)(6).The sid (b)(6) came back after circling and repeated hba1c with result 50 mmol/mol.The customer expected the arkray sal needs to see that the rfid changed and stop processing tubes because of possible sample mismatch or sample contamination.The sid (b)(6) repeated on standalone instrument with same result.There was no rerun rule configured for this assay.The wrong hba1c results reported out of the laboratory and then corrected later.There was no treatment changed due to wrong hba1c results reported.No further impact to patient management reported.

Event Description

The customer observed discrepant hba1c results for one sid (b)(6) on abbott glp sal arkray module.The customer received two hba1c results for one patient.The results provided were: sid (b)(6) using car 41006 initial=68 mmol/mol /repeated=50 mmol/mol; repeated on standalone module= 50 mmol/mol.The sid (b)(6) moved through glp to arkray access point in car 41006, the tac (tube assessment center) input module of the glp track read the barcode and it will link it to the car rfid (radio frequency identification) 41006.The glp sal (sample access line) read car rfid and got stuck there at access point due to sticking label.The customer push manually that car 41006.The arkray aspirated blood from next specimen in line and got results 68 mmol/mol for sid (b)(6).The sid (b)(6) came back after circling and repeated hba1c with result 50 mmol/mol.The customer expected the arkray sal needs to see that the rfid changed and stop processing tubes because of possible sample mismatch or sample contamination.The sid (b)(6) repeated on standalone instrument with same result.There was no rerun rule configured for this assay.The wrong hba1c results reported out of the laboratory and then corrected later.There was no treatment changed due to wrong hba1c results reported.No further impact to patient management reported.

Manufacturer Narrative

The glp technical group performed a review of the issue for the glp sal arkray ha-8180v (list number 06q62-01).Based on the available information within the complaint text and ticket system, glp technical group concluded there were no other tickets found to be similar to the current issue; no adverse trend was identified.The abbott automation solutions (aas) technical group performed an investigation based on the complaint information.The aas team determined that the car with the sample tube was pushed out of the access point (ap) area to resolve a traffic jam that was found on the track.Aas could not determine which car id was involved in the jam.Along with the caution provided in the operations manual, aas speculated that human intervention prevented the ap from correctly reading the position of the car and caused the error.Therefore, no further actions will be performed.Based on the complaint, the information suggests that no systemic issue or product deficiency was identified for glp sal arkray ha-8180v , serial (b)(6).

• Brand Name: GLP SAL ARKRAY HA-8180V
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer (Section G): ABBOTT AUTOMATION SOLUTIONS GMBH; sachsenkamp 5; hamburg 20097 ; GM 20097
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18504330
• MDR Text Key: 332792130
• Report Number: 3023268435-2024-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K213486
• Number of Events Reported: 1
• 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: 02/22/2024

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 Number: 06Q62-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/22/2024
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1