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

Catalog Number 03051315001

Device Problems Computer Operating System Problem (2898); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2015

Event Type  malfunction  

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 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.

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
• Type of Device: CLINICAL SAMPLE CONCENTRATOR; CFR 862.2310
• Manufacturer (Section D): ROCHE DIAGNOSTICS LTD.; forrenstrasse; rotkreuz, CH-63 43; SZ CH-6343
• Manufacturer (Section G): ROCHE DIAGNOSTICS LTD.; forrenstrasse; rotkreuz, CH-63 43; SZ CH-6343
• Manufacturer Contact: vincent stagnitto ; 1080 us hwy 202s; branchburg, NJ 08876-3733 ; 9082537569
• MDR Report Key: 5358143
• MDR Text Key: 36251632
• Report Number: 2243471-2016-00007
• Device Sequence Number: 1
• Product Code: JJH
• UDI-Device Identifier: 04015630924615
• UDI-Public: 04015630924615
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03051315001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2243471-02-22-2016-001-C
• Patient Sequence Number: 1