MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-01-10 for CLIN CHEM LDH 02P56-21 manufactured by Abbott Manufacturing Inc.
[64427287]
Lot/serial number was not provided by the customer; therefore, only a partial udi is known. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[64427288]
The customer stated that the architect analyzer generated a falsely elevated ldh result on one patient. The results provided were: initial =400 / repeat = 200 (normal range 125-220u/l). There was no additional patient information provided. There was no reported impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[68787932]
Evaluation of the customer issue included a review of the complaint text, trend reports, complaint searches, instrument logs review, and product labeling. There was no patient sample provided to assist in the investigation. A review of complaints for the product did not identify any issues or trends associated with the customer's complaint. A review of product labeling revealed adequate labeling for the handling of reagents, samples, interpretation of assay results, and troubleshooting of the instrument for this complaint issue. The customer's instrument history log file was reviewed from 21jun2016 through 21dec2016 and found 176 instances of error code 3375 (aspiration error), potentially indicating a presence of foam, bubbles, or fibrin in samples. There were also some instances of error code 0550 (instrument hard stops) in this timeframe indicating the cuvette washing was not completed, and that the cuvette wash (6052) procedure should be performed. The customer's maintenance file was reviewed for this timeframe and the cuvette wash (6052) procedure was not performed during those 6 months. Abbott recommends this procedure be completed after every 0550 error code in order to keep the cuvettes clean. Based upon the data available and the results of this investigation no malfunction or product deficiency was identified.
Patient Sequence No: 1, Text Type: N, H10
[74627992]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2017-00005 |
| MDR Report Key | 6239059 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-01-10 |
| Date of Report | 2017-04-28 |
| Date Mfgr Received | 2017-04-26 |
| Date Added to Maude | 2017-01-10 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 224667-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLIN CHEM LDH |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2017-01-10 |
| Catalog Number | 02P56-21 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |