MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-02-06 for COULTER ISOTON 4 DILUENT 8547148 manufactured by Beckman Coulter.
[5345886]
The customer reported that the hemoglobin (hgb) was high on 5c quality controls (qc) run on a coulter lh 500 hematology analyzer. In addition, the customer reported that there had been high hgb on startup. Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[12904312]
The field service engineer (fse) evaluated the instrument on (b)(4) 2015. The fse indicated that he observed hgb high on startup; however the results were within specification. The hgb voltage was also unstable. He cleaned the white blood cell (wbc) bath with a bleach solution; however, the problem persisted. The wbc bath holds wbc dilution for mixing and for collection of wbc and hgb data. The wbc bath was still cloudy after cleaning and was replaced to resolve the qc, background, and hgb voltage issues reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41963117]
Based on root cause, the suspect product was identified to be the reagent(s) used with the instrument. The first product; subsequent products are provided here; it is unknown which lots were in use at the time of the event. Therefore, expiration date and device manufacturing date are also unknown for this event. Brand name: coulter isoton iii diluent; catalog #: 8546733; lot #: 50793f through 50818f. Brand name: coulter isoton 4 diluent; catalog #: 8547148; lot #: 18206f. Brand name: coulter lh series diluent; catalog #: 8547194; lot #: 510409f through 510657f; m405237 through m503553. New information about the root cause was completed on 8/12/2015. A recall was completed and an important product notice letter was sent to customers on 09/09/2015. The root cause has been identified as lot to lot variation in the sodium sulfate used in the reagent, which resulted in a compromised white blood cell (wbc) bath in this event. In addition, the investigation found that the root cause identified would not cause or contribute...
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2015-00201 |
| MDR Report Key | 4492285 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-09 |
| Date of Event | 2015-01-09 |
| Date Mfgr Received | 2015-08-12 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2015-03-11 |
| 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 | 3 |
| Manufacturer Contact | MS. MIRANDA HOLLAND |
| Manufacturer Street | 11800 SW 147TH AVENUE, 32-S08 |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802031 |
| Manufacturer G1 | BECKMAN_COULTER |
| Manufacturer Street | 7381 EMPIRE DRIVE |
| Manufacturer City | FLORENCE KY 41042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 41042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER ISOTON 4 DILUENT |
| Generic Name | DILUENT, BLOOD CELL |
| Product Code | GIF |
| Date Received | 2015-02-06 |
| Model Number | NA |
| Catalog Number | 8547148 |
| Lot Number | 18206F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-06 |