MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-17 for ARCHITECT SIROLIMUS WHOLE BLOOD PRECIPITATION REAGENT 01L76-55 manufactured by Abbott Laboratories.
[2361793]
A customer had bloodwork performed for an unspecified reason and discovered that liver parameters were elevated. The customer contacted abbott to inquire whether a splash to the arm during disposal of an unknown architect reagent approximately one month prior could have caused an increase in liver test results. The customer reported that their skin was intact but no information was provided regarding which reagent, volume of reagent in contact with skin, length of exposure time, first aid measures taken to address the skin exposure, nor whether there was any skin irritation or allergic response. The customer provided no information regarding any medical treatment or diagnostic testing other than results of blood tests. There was no liver function testing prior to the event for comparison. The bloodwork results for the patient were reviewed by the abbott medical director. The patient results indicate that the customer has elevated liver enzymes but the tests were negative for (b)(6). Abbott reviewed the list of reagents supplied to this customer and the associated material safety data sheets. A few of the reagents shipped to this customer were identified as being potentially toxic if they came into contact with skin. These reagents do have the potential to impact the liver and a pre-existing liver condition may be aggravated by exposure. The reagent package insert for these reagents clearly state to wear suitable protective clothing, gloves and eye/face protection when handling these products. At the current time, without additional information, it is not possible to ascertain whether these reagents were the subject of the exposure incident. No specific information about the type of treatment the customer received was provided.
Patient Sequence No: 1, Text Type: D, B5
[9484428]
Liver dysfunction. Device handling issue in order to isolate the possible assays. We reviewed all architect assays that are utilized at the customer's facility and determined that architect cyclosporine whole blood precipitation reagent, list 1l75-55, architect sirolimus whole blood precipitation reagent, list 1l76-55 and architect tacrolimus whole blood precipitation reagent, list 1l77-55 all have the possibility of affecting the liver. Customer complaints for the three assays received to-date were reviewed to determine if others have experienced the same issue. Our review of this data did not identify any problematic complaint activity that would indicate this product is performing contrary to its claims. Additionally, the package inserts and material safety data sheets for the three assays were reviewed. This review did indicate that the assays do have the potential to affect the liver. However, safety precautions/instructions are provided to minimize the risk. The customer was referred to the precautions section of each assays package insert. Based on this investigation, we have concluded that the architect cyclosporine whole blood precipitation reagent, architect sirolimus whole blood precipitation reagent and architect tacrolimus whole blood precipitation reagent are performing as intended and meeting their safety, effectiveness and label claims.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2011-00690 |
| MDR Report Key | 2341250 |
| Report Source | 05 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-10-31 |
| Date of Event | 2011-05-27 |
| Date Mfgr Received | 2011-10-31 |
| Date Added to Maude | 2011-11-18 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT SIROLIMUS WHOLE BLOOD PRECIPITATION REAGENT |
| Product Code | NRP |
| Date Received | 2011-11-17 |
| Catalog Number | 01L76-55 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2011-11-17 |