MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-06-22 for ARCHITECT SIROLIMUS 1L76-25 manufactured by Abbott Laboratories.
[1404975]
The customer observed architect sirolimus reagent barcode read errors when reagent lot 80126m00 was in use. The issue was observed with only architect sirolimus reagents of this lot. The customer tried different kits of the same reagent lot, however, the same error was generated. The customer cleaned the barcode reader inspected the reagent bottles and the reagent labels appeared clean and undamaged. When compared to other reagent kits, the labels appeared to be the same. The customer was asked to perform barcode recalibration and then to re-scan reagent, however, the barcode error persisted. The customer requested an alternate lot of reagent as a replacement. The customer received the new reagent which was read successfully by the architect barcode reader and the issue was resolved. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8620568]
Concomitant medical device: architect i2000sr analyzer, list # 3m74-01, (b)(4). The cause of the architect sirolimus reagent barcode read error was poor print quality from a single barcode printer. A product recall was issued on 5/27/10 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other lots of architect sirolimus reagent were affected. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[8620786]
(b)(4). An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[8787177]
(b)(4). Architect i2000sr analyzer, list # 3m74-01, (b)(4). The cause of the architect sirolimus barcode read error was poor print quality from a single barcode printer. A product recall was issued on 5/27/10 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No architect sirolimus reagent lots were affected.
Patient Sequence No: 1, Text Type: N, H10
[21783657]
Mother underwent a surgical kyphoplasty procedure to treat pain from a compressed vertebra resulting from a fall when she was tripped by a dog. Her lung x-rays taken just prior to surgery showed no evidence of fibrosis. Her heart was also normal with no evidence of any arrhythmia or other anomalies prior to surgery. Approx one year post kyphoplastic surgery she developed sudden pulmonary fibrosis and extreme heart arrhythmia and was dead within 3 weeks of the first onset. Her drs were baffled as to the cause. Diagnosis or reason for use: bone cement used in kyphoplasty to separate and stabilize.
Patient Sequence No: 1, Text Type: D, B5
[21821508]
(b)(4). Architect i2000sr analyzer, list #3m74-01, (b)(4). The cause of the architect sirolimus barcode read error was poor print quality from a single barcode printer. A product recall was issued on 5/27/10 for architect sirolimus reagent lot 80162m100 and abbott customers were notified to discontinue and/or destroy any remaining inventory of this lot. No other architect sirolimus reagent lots were affected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00363 |
| MDR Report Key | 1731851 |
| Report Source | 01 |
| Date Received | 2010-06-22 |
| Date Mfgr Received | 2010-11-24 |
| Device Manufacturer Date | 2009-11-09 |
| Date Added to Maude | 2010-12-10 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-5/28/10-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT SIROLIMUS |
| Generic Name | CMIA FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS IN HUMAN BLOOD |
| Product Code | NRP |
| Date Received | 2010-06-22 |
| Catalog Number | 1L76-25 |
| Lot Number | 80162M100 |
| Device Expiration Date | 2011-05-03 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-22 |