MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LTD. COBAS AMPLIPREP INSTRUMENT; CLINICAL SAMPLE CONCENTRATOR; CFR 862.2310

Catalog Number	03051315001
Medical Device Problem Codes	Computer Operating System Problem (2898); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into this issue is currently on-going; roche requested the barcode from the customer site for further evaluation and investigation.The outcome of this investigation will be communicated through a follow-up report.(b)(4).
Event or Problem Description
A us customer filed a complaint case indicating that the hand-held barcode scanner used with the cobas ampliprep instrument mis-identified a sample barcode id.No results were erroneously reported as this was identified by the customer during troubleshooting.No harm was indicated through the complaint case.
Additional Manufacturer Narrative
Date of report 23-feb-2016.Date received by manufacturer 23-feb-2016.Conclusion: labeling deficiency; no failure detected; device operated within specifications.A us customer filed a complaint case indicating that the hand-held barcode scanner used with multiple roche molecular systems platforms mis-identified a sample barcode id.No results were erroneously reported as this was identified by the customer during troubleshooting.No harm was indicated through the complaint case.The investigation determined that the barcodes printed by the customer were of poor quality and out of specification.Analysis of the original barcodes confirmed multiple pixel errors on both duplicates of the received barcodes.An rea barcode verification of the original barcodes confirmed a print quality of grade f for barcodes.The main cause of the low grade (f) is the low decodability and high defect values which could be attributed to the observed pixel failures.The handheld barcode scanner performed as intended.The cause of the mis-identified barcode in this complaint was due to the customer's poor barcode print quality which was out of specification.To assure optimal performance on the roche systems/platforms, it is required that sample barcodes have a print quality of "iso/iec 15416 grade 2.5 - 4.0 former ansi x3, 182 - 1990 grade a or b (a=3.5 to 4.0 / b=2.5 to <3.5)".When utilizing the appropriate sample barcode print quality, no mis-identification will result.It is only with a poor quality barcode and manual scanned entry that misreading of a sample barcode could potentially occur, causing a theoretical misidentification of clinical samples.However, the likelihood of an event causing adverse health consequences is assessed as "not likely", since misreading the barcode would have to generate an (erroneous) barcode number identical to a barcode number generated for a different patient sample in which the same test was ordered.There is an unlikely probability that the sample with the erroneous barcode and the sample with the identical, correct, barcode for the same target exists.Additionally, the misread would be highly detectable as there would be one sample that did not have a result associated with it upon completion of the run capa has been initiated and any required corrective actions, including labeling updates, will be taken.Customers will receive a reminder notification regarding barcode print quality specifications.Fda has been provided with correction and removal report 2243471-02-22-2016-001-c.(b)(4).

• Brand Name: COBAS AMPLIPREP INSTRUMENT
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR; CFR 862.2310
• Manufacturer (Section D): ROCHE DIAGNOSTICS LTD.; forrenstrasse; rotkreuz, CH-63 43; SZ CH-6343
• MDR Report Key: 5358143
• Report Number: 2243471-2016-00007
• Device Sequence Number: 16261264
• Product Code: JJH
• UDI-Device Identifier: 04015630924615
• UDI-Public: 04015630924615
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Notification,Relabeling
• Type of Report: Followup
• Report Date (Section B): 02/23/2016

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: 03051315001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2016
• Supplement Report FDA Received Date: 02/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243471-02-22-2016-001-C
• Patient Sequence Number: 1