MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-06-14 for ABBOTT COMMANDER FPC 3A46-09 manufactured by Abbott Manufacturing, Inc..
[581750]
The customer stated that internal barcode reader on the abbott commander flexible pipetting center (fpc) is misreading pt sample barcode labels intermittently. The barcode labels are a combination of numeric and alpha-numeric. Sometimes erroneous symbols (%, $) are inserted but in some cases, an incorrect letter or number is inserted (e. G. "5" is read as "6", "n" is read as "k").
Patient Sequence No: 1, Text Type: D, B5
[7823595]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. This issue is occurring on 3 fpcs in one pool of instruments. The customer has a total of 9 fpcs. The abbott assay specialist has verified the barcode configurations on the fpcs are correct. The abbott field service rep (fsr) is also monitoring power issues at the account with noted construction that started 2 days before event. The barcode labels are purchased are code 39 and are a combination of numeric and alpha-numeric. The labels are attached at the collection sites and are the ones used for testing. The tubes are read on the fpc, tests are run on the abbott commander parallel processing center (ppc) and the results are sent to the host from the ppc. The ids are not manually entered. The barcode misreads are found during the customer review process. Barcode labels from the customer have been submitted for internal abbott testing. These barcodes are from 2 vendors. Current testing has not recreated the issue. Testing of the barcodes has determined there are some defects in the barcodes, which includes smeared white spaces and bars that are on the narrow side of the width range. The labels from one co are shorter than the other co's labels. At the customer site, a shield has been placed in the barcode area to keep stray light out of the read area. A conference call was initiated on 06/06/2006 to discuss the barcode issues. The barcoad misreads observed appeared to be a random occurrence. Troubleshooting is continuing with the fsr to swap the location of a fpc and monitor issues. The fpcs will be placed on line monitors. The customer is to print out destination maps as they run assays to check to see if misreads are occurring during the actual read. The customer is to perform further checks on results and barcode readings on samples reported out. Troubleshooting is ongoing at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2006-00040 |
| MDR Report Key | 808552 |
| Report Source | 05,06,07 |
| Date Received | 2006-06-14 |
| Date of Report | 2006-05-17 |
| Date of Event | 2006-05-17 |
| Date Mfgr Received | 2006-05-17 |
| Date Added to Maude | 2007-01-26 |
| 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 | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT COMMANDER FPC |
| Generic Name | AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS |
| Product Code | LQI |
| Date Received | 2006-06-14 |
| Model Number | NA |
| Catalog Number | 3A46-09 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 796034 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Baseline Brand Name | ABBOTT COMMANDER PPC |
| Baseline Generic Name | EIA FOR DETECTION OF HCV ANTIBODY |
| Baseline Model No | NA |
| Baseline Catalog No | 3A46-09 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-14 |