MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2009-11-12 for BAR CODE SCANNER SCC 06L89-01 manufactured by Jadak.
[1249659]
When the hand-held bar code scanner is used for entering (scanning) data under condition that the computer keyboard caps lock key is enabled, upper case letters encoded in the bar codes will be reported by the computer as lower case ones, and lower case letters will be reported as upper case ones. When the hand-held bar code scanner is used for entering data under condition that some other keyboard keys are enabled, data scanned can be altered such that those recognized by the m2000 scc may not match the codes contained on the bar code for all cases. There is impact to product functionality, such that the system may not track the sample identification correctly from sample input to reported results when the issue as described above occurs. This issue may result in pt sample identification mismatch, with a hazard of incorrect results reported. Additionally, it may cause a delay of one day if the scanner issue occurs on a calibrator or control. Overall risk is low.
Patient Sequence No: 1, Text Type: D, B5
[8362652]
A field correction letter (per fa-cam-nov2009-066) was sent out to abbott molecular customers informing them to be sure that the caps lock feature was not enabled or any other additional keyboard keys (such as the shift key) when using the hand-held bar code scanner. The customers were alerted to the fact that the m2000 instrument system may not be able to track the sample identification for pt samples, calibrators and controls correctly. They were informed that there is no impact to pt results; however, this issue could result in misidentification of pt sample id.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2009-00004 |
| MDR Report Key | 1527059 |
| Report Source | 00,07 |
| Date Received | 2009-11-12 |
| Date of Report | 2009-11-12 |
| Date of Event | 2009-10-15 |
| Date Mfgr Received | 2009-10-15 |
| Date Added to Maude | 2011-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAULA MARTIN |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617333 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAR CODE SCANNER SCC |
| Generic Name | BAR CODE SCANNER |
| Product Code | NZH |
| Date Received | 2009-11-12 |
| Model Number | 06L89-01 |
| Lot Number | ALL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JADAK |
| Manufacturer Address | 7279 WILLIAM BARRY BLVD. NORTH SYRACUSE NY 13212334 US 13212 3349 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-12 |