MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-11 for COBAS AMPLIPREP INSTRUMENT 03051315001 manufactured by Roche Diagnostics Ltd..
[36251632]
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).
Patient Sequence No: 1, Text Type: N, H10
[36251633]
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.
Patient Sequence No: 1, Text Type: D, B5
[41330865]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2016-00007 |
| MDR Report Key | 5358143 |
| Date Received | 2016-01-11 |
| Date of Report | 2016-02-23 |
| Date of Event | 2015-12-12 |
| Date Mfgr Received | 2016-02-23 |
| Date Added to Maude | 2016-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Manufacturer G1 | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ, CH-6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2243471-02-22-2016-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR; CFR 862.2310 |
| Product Code | JJH |
| Date Received | 2016-01-11 |
| Catalog Number | 03051315001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Address | FORRENSTRASSE ROTKREUZ, CH-6343 SZ CH-6343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-11 |