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 2017-05-05 for CLINICAL CHEMISTRY LACTATE DEHYDROGENASE 02P56-21 manufactured by Abbott Manufacturing Inc.
[74596944]
A review of complaint tracking and trending metrics was performed and identified no related adverse or non-statistical trends in conjunction with the complaint issue currently under evaluation for this product. The architect clinical chemistry lactate dehydrogenase reagent assay insert and the architect operations manual contain information to address the current customer issue. As the reagent lot has expired, no testing was performed. Based on the information obtained through this evaluation and the information from the customer site, there is evidence to reasonably suggest that a product malfunction occurred. However, no systemic issue or product deficiency was identified. Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided.
Patient Sequence No: 1, Text Type: N, H10
[74596945]
The customer reports falsely elevated clin chem ldh assay results being generated on patient samples tested on the architect c8000 analyzer. Controls trend high but still within specifications. Proficiency samples have always passed. The customer uses serum patient samples and always runs samples in a 1:3 dilution. The customer notes that when the samples are retested the following day, values drop significantly into the normal reference range (12% to 47% decrease). When using reagent lot 11911un15, the customer reported the following values (day 1, day 2): sample 1: 277, 243 u/l; sample 2: 336, 189 u/l; sample 3: 679, 536 u/l; sample 4: 171, 149 u/l; and sample 5: 200, 176 u/l. These same types of ranges were seen on a second architect csystem in the lab. The customer uses a normal reference range of 125 - 220 u/l. Some results have been questioned by physicians as being higher than expected. There is no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2017-00186 |
| MDR Report Key | 6549271 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-05 |
| Date of Report | 2017-05-05 |
| Date Mfgr Received | 2017-04-21 |
| Device Manufacturer Date | 2015-08-10 |
| Date Added to Maude | 2017-05-05 |
| 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 | CLINICAL CHEMISTRY LACTATE DEHYDROGENASE |
| Generic Name | LACTATE DEHYDROGENASE |
| Product Code | CFJ |
| Date Received | 2017-05-05 |
| Catalog Number | 02P56-21 |
| Lot Number | 11911UN15 |
| Device Expiration Date | 2016-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-05-05 |