MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC PRISM NEXT ANALYZER; AUTOMATED IMMUNOASSAY ANALYZER,

Catalog Number	06A36-34
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2017
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.(b)(6).
Event or Problem Description
The customer reports that the abbott prism next analyzer misread sample barcode label (b)(6) as 831646.No error messages were generated and the label does not appear to be damaged.The customer re-read the barcode on the analyzer the next day and the correct identification number was read.There is no impact to patient/donor management reported.
Additional Manufacturer Narrative
An abbott field service representative (fsr) visited the customer site to evaluate the customer issue.The fse was unsuccessful in attempting to recreate the barcode read error reported by the customer.The fsr reported that the integrity of the sample barcode looked acceptable.The customer returned the sample barcode to abbott for further evaluation by a technical engineer.The label was graded as a b/c, both the barcode grade and narrow bar width were within abbott recommended guidelines for sample barcode label guidelines found in the prism operations manual.Additionally, the barcode label was acceptable with no noticeable defects.The sample barcode labels are not an abbott product; customers create their own labels per the guidelines in the abbott prism next operations manual.The misread issue was not reproducible when the sample was tested on two prism instruments in-house.A specific cause for the sample misread at the customer site could not be determined.Review of the prism next serial number 01523 service history did not identify contributing factors on or around the date of the complaint.There were no subsequent contacts from the customer regarding sample barcode label misreads.A review of complaint tracking and trending metrics was performed and identified no related adverse trends in conjunction with the complaint issue currently under evaluation for this product.No non-conformances or potential non-conformances related to the barcode reader scanner were identified.The abbott prism next operations manual and the abbott prism customer service reference guide both contain information to address the current customer issue.Based on the results of this evaluation and the information from the customer site, there is evidence to reasonably suggest a product malfunction occurred as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, no systemic issue or product deficiency was identified.

• Brand Name: PRISM NEXT ANALYZER
• Common Device Name: AUTOMATED IMMUNOASSAY ANALYZER,
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 6516615
• Report Number: 1628664-2017-00137
• Device Sequence Number: 16365123
• Product Code: MZA
• UDI-Device Identifier: 00380740008574
• UDI-Public: 00380740008574
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK970042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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 Catalogue Number: 06A36-34
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1