MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-10 for MICROSCAN PANELS UNK manufactured by Siemens Healthcare Diagnostics Inc.
[5021348]
It was reported that the barcode printer was skipping blank labels and the only way to get it to stop would be to cycle and power on the printer. The customer had to repair the bar code label and that is when the print order was affected and resulted in a mix up of labels. Customer indicated that barcode printer was not the cause of mixed up labels. Approximately 11 panels were affected with incorrect barcodes. It is unk how many incorrect results were initially reported to the physicians. When the customer discovered the mixed up, isolates were re-tested. The corrected results were issued and reported to the physician. It is unk when the label mix up started to occur. The specific info about the treatment was not reported.
Patient Sequence No: 1, Text Type: D, B5
[12420076]
(b)(4). The customer indicated that the microscan barcode printer was not at fault for this issue. The mixed up of specimen issues in their facility have been resolved with the implementation of a new process to confirm labels before attaching to the panels. The model numbers of the affected 11 panels ere not reported. Calibration of the barcode printer was performed on (b)(6) 2014 and the barcode printer skipped blank labels was resolved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00040 |
| MDR Report Key | 4173501 |
| Report Source | 05 |
| Date Received | 2014-10-10 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-09-25 |
| Date Mfgr Received | 2014-09-25 |
| Date Added to Maude | 2014-11-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743031 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSCAN PANELS |
| Generic Name | NONE |
| Product Code | LRG |
| Date Received | 2014-10-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | WEST SACRAMENTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-10 |