MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-16 for ISOTRAK SIM.SY2 STRONTIUM-90 TRANSFER STANDARD SIRB10787 manufactured by Qsa-global Inc..
[17865870]
On (b) (6) 2007, qsa global customer service was informed by a (b) (6) of the following incident. (b) (6) practitioners improperly calibrated dose calibrators using the decay corrected sr-90 activity of the sr-90/y-90 reference standard instead of the y-90 equivalent activity as described in the handling instructions. Since the decay corrected sr-90 activity was lower than the y-90 equivalent activity, subsequent dispensing measurements of the (b) (6) y-90 (b) (6) were in error. This resulted in a pt being administered a therapeutic dose in excess of the prescribed dose. This incident occurred (b) (6) 2007. The investigation concluded that the product label on the device container may have contributed to the user error, and should be amended. The effect on the pt involved in this incident is unk. The hospital contact has referred to the (b) (6) labeling packaging insert for info on possible effects, but has declined to provide further info. Note: this report is being made to resolve an observation by an fda inspector and reported on form (b) (4), dated 5/23/2008.
Patient Sequence No: 1, Text Type: D, B5
[17982164]
Qsa (b) (4)under took corrective action in the form of re-labeling the device shield container as reported under 21 usc 360 as a prudent and responsible measure to prevent a similar user error. At the time of the event investigation qsa had no info indicating the pt involved was injured or that medical intervention had been necessary. The potential for medical intervention to mitigate the risk of injury to a pt in the event of a recurrence was based on the literature provided by the medical facility concerning the use of the (b) (6) y-90 zevalin in excessive dose levels. Qsa did not at the time believe the conditions or reported event met the criteria for medical device reporting under 21 cfr 803. This was based on the lack of evidence of injury to the subject in question or need for medical intervention. In addition, qsa was aware that significantly larger doses of the (b) (6) had been used without adverse effects. Apparent cause: the primary cause of this incident is deviation from the supplied instructions for use of the sr-90 transfer standard. Proceeding with the calibration process without the source certificate is the proximate cause of the calibration error leading to the overdose. A contributing cause to the incident is the ambiguous labeling of the source container. The use of inconsistent labeling set the stage for the error to occur. Common practice in the field is to accept the info on the device or its container as the correct information. Conclusion: the sr-90/y-90 transfer standard is labeled in a way that can lead to improper use of the device when calibrating dose calibrators. As evidenced by the incident reported, improper calibration can result in administering an overdose of the (b) (6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226007-2008-00001 |
| MDR Report Key | 1062839 |
| Report Source | 06 |
| Date Received | 2008-06-16 |
| Date of Report | 2008-06-13 |
| Date of Event | 2007-06-19 |
| Date Mfgr Received | 2007-06-20 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2010-04-09 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | CATHLEEN ROUGHAN |
| Manufacturer Street | 40 NORTH AVE. |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7815058210 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Removal Correction Number | 1226007-7/30/07-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOTRAK SIM.SY2 STRONTIUM-90 TRANSFER STANDARD |
| Generic Name | SOURCE, CALIBRATION, SEALED, NUCLEAR |
| Product Code | IXD |
| Date Received | 2008-06-16 |
| Model Number | SIM.SY2 |
| Catalog Number | SIRB10787 |
| Lot Number | 13001B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QSA-GLOBAL INC. |
| Manufacturer Address | BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-16 |