MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-04-17 for SPECTRUM SERIES II 1370-48 manufactured by Abbott Mfg., Inc..
[7769902]
A review of the spectrum operation was done, as well as a product literature check for info available to the customer. Inspection of the test parameter file showed that the customer had the calibration interval for calcium set at 720 hours instead of the recommended 24 hours. It also found that the upper linear limit was correctly set at 16 mg/dl. Failure to calibrate calcium at the mfr's specified intervals may result in instability of the calibration curve which can affect sample result values. The spectrum analyzer is equipped with adequate software safeguards to prevent the system from automatically printing a known unacceptable result. The reagent package insert also has highlighted test for the operator to ensure that critical and timely info, such as the calibration intervals, is presented to the customer at all times. The customer was not able to provide any data on lot numbers of reagent in use, no quality control, no maintenance records, and whether applicable error codes were present or absent at the time of the incident, therefore, no cause can be determined. Evaluation complete-final report.
Patient Sequence No: 1, Text Type: N, H10
[19776723]
On 7/8/96, the account reported a calcium result of 18. 0 on a pt with multiple myeloma. The pt was sent to the er on 7/11/96, and an iv infusion was started. The iv was discontinued 4 hours later when the lab gave new results. A repeat testing of the original samplle recovered 8. 7 and a new sample recovered 9. 1. The pt had been hospitalized several weeks prior to this incident, and released when the oncologist documented a change in regiment to be carried out with pt only visiting the clinic for cytoxan, bcnu, alkeran, and prednisone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-1997-00040 |
| MDR Report Key | 86129 |
| Report Source | 05,06 |
| Date Received | 1997-04-17 |
| Date of Report | 1997-04-15 |
| Date of Event | 1996-07-08 |
| Date Mfgr Received | 1997-03-18 |
| Device Manufacturer Date | 1992-11-01 |
| Date Added to Maude | 1997-04-25 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRUM SERIES II |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LCI |
| Date Received | 1997-04-17 |
| Model Number | NA |
| Catalog Number | 1370-48 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 85323 |
| Manufacturer | ABBOTT MFG., INC. |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-17 |